[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"carotid-artery-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:carotid-artery-diseases":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,40,79,111,143,166,193,212,234,261,283,310,333,353,371,387,418,442,471,492,525,552,577],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100617768","intervascular-post-market-clinical-follow-up-pmcf-registry-100617768",false,"NCT07322913","Intervascular Post-Market Clinical Follow-Up (PMCF) Registry","Post-Market Clinical Follow-up Registry to Evaluate the Safety and Performance of the Intervascular Vascular Grafts and Patches in Patients Undergoing Bypass, Replacement, or Repair of Aortic, Peripheral, or Carotid Arteries","Inclusion Criteria:\n\n* Willing, and able to provide legally-effective written informed consent (as required by Institutional Review Board or Ethics Committee)\n* Male and female patients that have undergone bypass, replacement or repair of the peripheral arteries, aorta, or carotid artery using the Intervascular Vascular Grafts and Patches (Intergard Standard, Hemashield, Intergard Silver, Intergard Synergy)\n* Were at least 18 years of age at the time of the procedure\n* Available records for data collection with a minimum of 3 years (36 months) of data\u002Ffollow-up.\n\nExclusion Criteria:\n\n* Active infection in the region of device placement at the time of implantation of the Intergard Standard and Hemashield Vascular Graft or Patch.","ALL","18 Years",{"count":19,"type":20},1200,"ESTIMATED","OBSERVATIONAL","The purpose of this registry is to evaluate the long-term safety and performance of Intervascular Vascular Grafts and Patches (Intergard Standard, Hemashield, Intergard Silver, Intergard Synergy) for bypass, repair or replacement of aortic, peripheral, or carotid arteries. This registry is intended to further define the expected product lifetime of the devices and to collect data related to usefulness of the antimicrobial coatings.",[24,25,26],"Carotid Artery Diseases","Aortic Diseases","Peripheral Arterial Diseases","RECRUITING","2026-06-12",{"date":30,"type":31},"2026-06-15","ACTUAL",{"date":33,"type":31},"2025-12-19",{"date":35,"type":20},"2026-12",{"name":37,"class":38},"Intervascular","INDUSTRY",4,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":62,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100638937","phase-4-carotid-ultrasound-based-strategy-for-primary-prevention-of-cardiovascular-events-in-inflammatory-rheumatic-disease-prevener-100638937","NCT07611747","Carotid Ultrasound-Based Strategy for Primary Prevention of Cardiovascular Events in Inflammatory Rheumatic Disease (PREVENER)","Randomized Clinical Trial to Assess the Efficacy and Safety of a Primary Prevention Strategy for Cardiovascular Events in Patients With Inflammatory Rheumatic Diseases Based on the Use of Carotid Ultrasound","PREVENER","Inclusion Criteria:\n\n1. Patients aged ≥50 years who have provided written informed consent.\n2. Fulfillment of classification criteria for at least one of the following inflammatory rheumatic diseases:\n\n   * Rheumatoid arthritis (RA) according to ACR\u002FEULAR 2010 criteria\n   * Psoriatic arthritis (PsA) according to CASPAR criteria\n   * Axial spondyloarthritis (AxSpA) according to ASAS criteria\n   * Systemic lupus erythematosus (SLE) according to ACR\u002FEULAR 2019 criteria\n3. Low-to-moderate cardiovascular risk according to SCORE2\u002FOP classification.\n\nExclusion Criteria:\n\n1. Presence of previous cardiovascular events, type 2 diabetes mellitus, familial hypercholesterolemia, or chronic kidney disease resulting in classification as high or very high cardiovascular risk.\n2. Prior carotid ultrasound examination with subsequent therapeutic intervention derived from its results, either in the context of a research study or routine clinical practice.\n3. Contraindications to lipid-lowering therapy, including recent history of alcoholism, active liver disease, or unexplained and persistent elevation of serum transaminases exceeding three times the upper limit of normal (applicable to statins and ezetimibe).","50 Years",{"count":50,"type":20},1944,"INTERVENTIONAL",[53],"PHASE4","PREVENER is a randomized, open-label, multicenter, phase IV clinical trial designed to evaluate the efficacy and safety of a carotid ultrasound-based strategy for the primary prevention of cardiovascular events in patients with inflammatory rheumatic diseases (IRD).\n\nPatients with IRD, including rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (AxSpA), and systemic lupus erythematosus (SLE), have a 50% higher risk of cardiovascular (CV) events compared to the general population. However, conventional CV risk scores (SCORE2\u002FOP) systematically underestimate this risk, leaving many high-risk patients without appropriate preventive treatment.\n\nPatients aged ≥50 years with IRD and low-to-moderate CV risk according to SCORE2\u002FOP will be randomized 1:1 to either an experimental group (carotid ultrasound to detect subclinical atherosclerosis) or a control group (standard care according to ESC 2021 guidelines). Patients in the experimental group with carotid plaques will be reclassified as very high CV risk and treated with high-intensity statins (LDL target \\\u003C55 mg\u002FdL). The primary endpoint is the incidence of major adverse cardiovascular events (MACE) over 48 months of follow-up.",[56,57,58,59,60,61,24],"Rheumatoid Arthritis (RA)","Psoriatic Arthritis (PsA)","Axial Spondy","Systemic Lupus Erythematosus (SLE)","Caridovascular Disease","Atherosclerosis",[63,64,65,66,67],"Carotid ultrasound","Carotid plaques","Subclinical atherosclerosis","Cardiovascular prevention","Inflammatory rheumatic diseases","2026-05-20",{"date":70,"type":31},"2026-05-28",{"date":72,"type":31},"2026-04-22",{"date":74,"type":20},"2031-12",{"name":76,"class":77},"Instituto de Investigación Marqués de Valdecilla","OTHER",17,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":86,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":51,"phases":89,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100537326","highest-efficacy-of-dual-antiplatelet-therapy-after-carotid-artery-stenting-in-high-bleeding-risk-patients-100537326","NCT06276374","Highest Efficacy of Dual Antiplatelet Therapy After Carotid Artery Stenting in High Bleeding Risk Patients","Clinical Trial to Obtain the Highest Efficacy of Dual Antiplatelet Therapy After Carotid Artery Stenting in High Bleeding Risk Patients","Inclusion Criteria:\n\n1. Patients ≥19 years\n2. Symptomatic patients with carotid artery stenosis\\* greater than 50% and asymptomatic patients with carotid artery stenosis\\* greater than 70% who are scheduled to undergo or who have undergone carotid artery stenting\n3. High bleeding risk is defined as a Bleeding Academic Research Consortium type 3 or 5 bleeding risk of ≥4% at 1 year or a risk of an intracranial hemorrhage (ICH) of ≥1% at 1 year, Patients who meet at least one of the criteria for high bleeding risk\\*\\* below\n\n   * The degree of stenosis is determined using the method performed in the North American Symptomatic Carotid Endarterectomy Trial.\n\n     * Criteria for high bleeding risk (≥ 1)\n\n       * Incidence of non-access site bleeding within 12 months prior to stenting (gastrointestinal tract or hematuria)\n       * Presence of BARC type 3 or 5 bleeding regardless of the onset time, but the cause has not been completely cured.\n       * Adults aged ≥75 years\n       * Thrombocytopenia \\\u003C 100,000\u002Fmm3 (based on the screening test)\n       * Blood clotting disorders that increase bleeding (Von Willebrand disease, factor VII, VIII, IX, and XI deficiency)\n       * Patients with anemia defined as hemoglobin \\\u003C12g\u002FdL in men and \\\u003C11g\u002FdL in women or patients who donated blood within 4 weeks (based on the screening test)\n       * Patients received steroids or NSAIDs for ≥4 weeks\n       * Patients with active malignancy (except for nonmelanoma skin cancer)\n       * Renal disease (dialysis, transplantation, Estimated Glomerular Filtration Rate \\\u003C 60ml\u002Fmin per 1.73m2)\n       * Liver disease (cirrhosis with portal hypertension)\n       * Cerebral microbleeds ≥ 5\n       * Stroke or transient ischemic attacks within 6 months or Transient amaurosis fugax\n       * Incidence of nontraumatic intracerebral hemorrhage regardless of duration or incidence of traumatic intracerebral hemorrhage within 12 months\n\nExclusion Criteria:\n\n1. Incidence of net clinical events, including cardiovascular and cerebrovascular accidents or major bleeding events, within 30 days following carotid artery stenting\n2. Discontinuation of dual antiplatelet therapy within 30 days after carotid stent implantation (However, use of a single antiplatelet therapy within 7 days due to acute infection and trauma is allowed, but dual antiplatelet therapy must be administered at 28 to 30 days after carotid stent implantation)\n3. Coronary artery stenting or other vascular stenting or vascular recanalization within 1 year (Revascularization surgery that requires CABG(Coronary Artery Bypass Graft) and other dual antiplatelet therapy)\n4. Aspirin or clopidogrel hypersensitivity\n5. Pregnant or breastfeeding women (Women of childbearing need to check for pregnancy using urine or blood tests before enrollment, and use appropriate contraception methods during the clinical trial period)\n6. Patients requiring anticoagulation for ≥12 months\n7. Patients requiring administration of other antiplatelet therapies\n8. Patients who are participating in another intervention clinical trial","19 Years",{"count":88,"type":20},1556,[90],"NA","The optimal duration of dual antiplatelet therapy (DAPT) after carotid artery stenting (CAS) in patients at high bleeding risk (HBR) has not been established in randomized controlled trials. Current practice largely extrapolates from percutaneous coronary intervention (PCI) trials, but anatomical and procedural differences between coronary and carotid arteries limit the validity of this approach.\n\nThe CHET trial is a multicenter, randomized, open-label, superiority trial designed to compare two DAPT durations after CAS in patients at HBR. After CAS, all eligible patients receive aspirin (100 mg daily) and clopidogrel (75 mg daily) for a 30-day enrichment period. Patients who remain free of net clinical events at day 30 are randomized 1:1 to either single antiplatelet therapy (SAPT; aspirin 100 mg or clopidogrel 75 mg daily, at the treating physician's discretion) for 11 months, or continued DAPT for 11 months.\n\nThe primary hypothesis is that abbreviated DAPT followed by SAPT is superior to prolonged DAPT in reducing clinically significant bleeding (Bleeding Academic Research Consortium \\[BARC\\] type 2, 3, or 5) from 30 days to 12 months after CAS, while maintaining noninferiority in net clinical outcomes (composite of nonfatal stroke, nonfatal myocardial infarction, cardiovascular death, and major bleeding \\[BARC type 3 or 5\\]).\n\nA total of 1,556 participants (778 per group) will be enrolled across multiple comprehensive stroke centers in the Republic of Korea. Patients will be followed at 5 and 11 months after randomization, with subsequent annual follow-up (in-person or by telephone) until study completion to capture long-term clinical events.",[24],[94,95,96,97,98,99,100],"Carotid Artery Stenting","Dual Antiplatelet Therapy","High Bleeding Risk","Aspirin","Clopidogrel","BARC bleeding","Stroke prevention","2026-05-06",{"date":103,"type":31},"2026-05-11",{"date":105,"type":31},"2024-07-15",{"date":107,"type":20},"2030-12-31",{"name":109,"class":77},"Woo-Keun Seo",1,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":119,"targetDuration":121,"studyType":21,"phases":4,"briefSummary":122,"conditions":123,"keywords":128,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":110},"100615773","oral-microbiome-in-carotid-atherosclerosis-100615773","NCT07296965","Oral Microbiome in Carotid Atherosclerosis","The Role of the Oral Microbiome in Carotid Atherosclerosis: Investigating in a Cross-sectional Study the Microbial Influence on Plaque Development and Vulnerability Based on Biobank Data","OMICA","Inclusion Criteria:\n\n* Confirmed internal carotid artery (ICA) stenosis on preoperative photon-counting computed tomography (CTA)\n* Adults (≥18 years) undergoing carotid endarterectomy at Semmelweis University.\n* Eligible for surgery based on standard anesthesiologic evaluation.\n* Willing and able to provide written informed consent for participation and sample collection.\n\nExclusion Criteria:\n\n* Active systemic infection or current antibiotic therapy within 30 days before surgery.\n* Immunosuppressive therapy or immunodeficiency disorders.\n* Inability to undergo MRI (e.g., pacemaker, metallic implants, severe claustrophobia).\n* Pregnancy or lactation.\n* Malignancy under active treatment.\n* Prior carotid surgery or stenting on the same side.\n* Refusal or inability to provide informed consent.",{"count":120,"type":20},200,"1 Year","The goal of this observational study, called OMICA (Oral Microbiome in Carotid Atherosclerosis), is to learn how bacteria living in the mouth may influence the development and stability of plaques in the carotid arteries, which supply blood to the brain. Plaque buildup in these arteries can lead to stroke.\n\nResearchers want to understand whether certain oral bacteria are linked to plaque vulnerability, meaning a higher chance that the plaque will rupture and cause a stroke.\n\nThe study will include a cohort of adults scheduled for carotid endarterectomy at Semmelweis University. Participants will be enrolled in the Semmelweis University Carotid Biobank project.\n\nThe main questions the study aims to answer are:\n\nDo people with more severe gum disease or tooth infection have a higher number of bacteria in their carotid plaques, and are those plaques more likely to rupture?\n\nAre the bacteria found in vulnerable plaques different from those in stable plaques?\n\nAre similar bacteria found in the mouth, gut, and plaques, suggesting that bacteria may travel through the body?\n\nWhat participants will do:\n\nHave their oral health checked before surgery, including an exam of gum disease and tooth infections.\n\nProvide microbiome samples from the mouth, anus, urine, and carotid plaque (taken during surgery).\n\nHave preoperative photon-counting computed tomography (CT) performed to assess plaque stability and study eligibility.\n\nAll samples and imaging data will be analyzed to identify bacterial species and their relationship to plaque type.\n\nThe study does not involve any experimental treatment or medication. Participation adds no significant medical risk beyond standard care.\n\nResearchers will compare bacterial patterns between people with vulnerable plaques and those with stable plaques to identify microbial signatures linked to carotid plaque instability.\n\nThe results may help create future microbiome-based risk models for detecting people at higher risk of stroke or severe atherosclerosis.",[124,125,126,127,24],"Atherosclerosis Cardiovascular Disease","Atherosclerosis of Artery","Carotid Artery Plaque","Periodontitis",[129,130,131,61,132,133,134],"Oral Microbiome","Carotid Plaque","Plaque vulnerability","Periodontal disease","Biobank study","Microbial colonization","2026-04-21",{"date":72,"type":31},{"date":138,"type":31},"2025-11-01",{"date":140,"type":20},"2029-11-01",{"name":142,"class":77},"Semmelweis University Heart and Vascular Center",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":51,"phases":151,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":156,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":110},"100589700","early-phase-1-study-to-image-inflammatory-activity-of-a-fluorescence-imaging-agent-in-excised-human-artery-plaques-100589700","NCT06957821","Study to Image Inflammatory Activity of a Fluorescence Imaging Agent in Excised Human Artery Plaques","Inclusion Criteria:\n\n* Must have an established diagnosis of severe carotid or peripheral arterial disease (ischemic or aneurysmal) requiring surgery and be sufficiently healthy to undergo surgery\n* Must be age of 18 years or older\n* Must be able to give informed consent\n* Women with childbearing potential must have a negative pregnancy test\n* Estimated glomerular filtration rate ≥ 60 mL\u002Fmin\u002F1.73 m2 (mild renal impairment\n\nExclusion Criteria:\n\n* History of allergic reaction to oral or intravenous contrast agents\n* History of allergic reaction to polyethylene glycol (PEG)\n* History of allergic or anaphylactic reactions\n* Participants who have taken an investigational drug within 14 days of enrollment.\n* Participants with hemodynamic instability\n* Any history of renal failure (estimated Glomerular Filtration Rate (eGFR) \\\u003C60ml\u002Fmin\u002F1.73 m2)\n* Pregnant or lactating females\n* Participants with uncontrolled hypertension defined as persistent systolic blood pressure \\> 180 mm Hg, or diastolic blood pressure \\> 110 mm Hg; those subjects with known HTN should be under these values while under pharmaceutical therapy\n* Severe concurrent illnesses including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, COPD or asthma requiring hospitalization within the past 12 months, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements",{"count":150,"type":20},25,[152],"EARLY_PHASE1","Active inflammation plays a key role in causing Coronary Artery Disease (CAD) and Peripheral Arterial Disease (PAD). Since inflammation is so important in how these diseases start, are diagnosed, and treated, being able to see it clearly in each patient could lead to more personalized and effective care - and may help prevent heart attacks. Right now, there's no imaging technology available to clearly see inflammation inside the coronary arteries.\n\nThe investigators hope to learn how an imaging drug; called LUMISIGHT (Pegulicianine) can help detect inflammation in blood vessels compared with saline. If the investigators find out that LUMISIGHT is active in humans, the investigators might be able to use it for detecting plaque risk in the future.",[24,155],"Peripheral Arterial Disease","NOT_YET_RECRUITING","2026-04-15",{"date":159,"type":31},"2026-04-20",{"date":161,"type":20},"2026-06",{"date":163,"type":20},"2029-12",{"name":165,"class":77},"Massachusetts General Hospital",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":51,"phases":176,"briefSummary":177,"conditions":178,"keywords":180,"overallStatus":156,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":4},"100632318","study-of-the-shockwave-medical-skyrunner-carotid-intravascular-lithotripsy-ivl-system-for-the-treatment-of-calcified-carotid-arteries-prior-to-trans-femoral-stenting-skyward-trans-femoral-ide-investigational-device-exemption-study-100632318","NCT07512128","Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Femoral Stenting (SKYWARD Trans-Femoral IDE [Investigational Device Exemption] Study)","Prospective, Multi-center, Single-arm Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Femoral Stenting (SKYWARD Trans-Femoral IDE Study)","SKYWARD TF","General Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Patient is able and willing to comply with all assessments in the study.\n3. Patient has been informed of the nature of the study, agrees to participate and has signed the approved informed consent form.\n4. Patient approved for inclusion by a Patient Screening Committee.\n5. Patient must have a life expectancy \\> 1 year at the time of the index procedure, in the opinion of the investigator at the time of enrollment, with no planned major cardiac intervention or surgery within 30 days following the index procedure.\n\n   Angiographic Inclusion Criteria:\n6. Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the carotid bifurcation.\n7. Target lesion must meet all requirements for commercially available trans-femoral stent systems (refer to IFU for requirements) and investigator intends to treat the target lesion with a single stent.\n8. Patient must meet one of the following criteria regarding neurological symptom status and degree of stenosis by duplex ultrasound in combination with CT or MR angiography:\n\n   1. Symptomatic: ≥ 50% stenosis of the internal carotid artery and the patient has a history of stroke, TIA and\u002For amaurosis fugax within 180 days of the procedure ipsilateral to the carotid artery to be treated.\n\n      OR\n   2. Asymptomatic: ≥ 70% stenosis of the internal carotid artery without any neurological symptoms.\n9. Patient has evidence of circumferential calcification of the stenotic lesion defined as ≥ 3 mm thickness of calcification as determined by Computed Tomography Angiography (CTA). MR angiography may be used in place of CTA for patients with a relative or absolute contraindication to CTA.\n10. Patient is high risk for CEA defined as meeting at least one anatomic or clinical high-risk condition listed below:\n\nAnatomic High Risk Inclusion Criteria:\n\n* Target lesion at or above C2 (level of jaw) or below the clavicle\n* Inability to extend the head due to cervical arthritis or other cervical disorders\n* History of radiation treatment to the neck or radical neck dissection\n* Prior head and neck surgery in the region of the carotid artery\n* Spinal immobility of the neck\n* Tracheostomy or tracheostoma\n* Hostile neck or surgically inaccessible lesion\n* Laryngeal palsy or laryngectomy\n* Severe tandem lesions (total length must be ≤ 30 mm and must be covered with one stent)\n* Occlusion of the contralateral CCA or ICA\n* Severe bilateral ICA stenosis\n\nClinical High-Risk Inclusion Criteria\n\n* Patient is ≥ 70 years of age.\n* Patient has congestive heart failure (CHF) - New York Heart Association (NYHA) Functional Class III or IV.\n* Patient has severe pulmonary disease (COPD) with either FEV \\\u003C 50% predicted or chronic oxygen therapy or resting PO2 of \\\u003C 60 mmHg (room air).\n* Patient has a history of angina Canadian Cardiovascular Society (CCS) class 3 or 4 or unstable angina.\n* Patient has known severe left ventricular dysfunction LVEF \\\u003C 30%.\n* Patient had a myocardial infarction \\> 72 hours and \\\u003C 6 weeks prior to procedure.\n* Coronary artery disease with two or more vessels with ≥ 70% stenosis.\n* Planned coronary artery bypass grafting (CABG) or valve replacement surgery between 31 and 60 days after index procedure.\n* Patient has permanent contralateral cranial nerve injury\u002Fparalysis.\n* Patient has chronic renal insufficiency (serum creatinine ≥ 2.5 mg\u002FdL). Note that patients on dialysis are excluded from study consideration per exclusionary criterion #13.\n* Planned abdominal aortic aneurysm repair or peripheral vascular surgery between 31 to 60 days after index procedure.\n\nGeneral Exclusion Criteria:\n\n1. Patient has alternative source of cerebral embolus, including but not limited to:\n\n   1. a history of chronic atrial flutter or atrial fibrillation, or paroxysmal atrial flutter or atrial fibrillation requiring chronic anticoagulation\n   2. knowledge of cardiac sources of emboli (e.g. left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, hemodynamically significant aortic stenosis, endocarditis, mitral stenosis, or left atrial myxoma)\n   3. recently (\\\u003C 60 days) replaced\u002Frepaired heart valve (either surgically or percutaneously).\n2. Patient has a history of spontaneous intracranial hemorrhage within the past 12 months, a hemorrhagic transformation of an ischemic stroke within the past 60 days or has had a recent stroke (\\\u003C 7 days) of sufficient size (on CT or MRI) to place the patient at risk of hemorrhagic conversion during the procedure.\n3. Patient with a history of major stroke with substantial neurological deficit (NIHSS ≥ 5 or mRS ≥ 3) within 1 month of index procedure.\n4. Patient has had a TIA, or amaurosis fugax within 48 hours prior to the procedure.\n5. Patient has neurologic illnesses within the past 2 years characterized by fleeting or fixed neurologic or cognitive deficit which cannot be distinguished from TIA or stroke.\n6. Patient has an intracranial tumor.\n7. Patient has an unresolved\u002Funcorrected bleeding disorder.\n8. Patient had a myocardial infarction (MI) within last 72 hours prior to index procedure.\n9. Patient has history of intolerance or allergic reaction to contrast material that cannot be adequately premedicated or to any of the required study medications (i.e., antiplatelet agents, statins) or device materials (refer to IFUs).\n10. Female patients who are pregnant, nursing, or may become pregnant.\n11. Patient is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached its primary endpoint.\n12. Patient has other medical, social, or psychological problems that, in the opinion of the investigator, would present difficulty in complying with protocol requirements.\n13. Patient is on renal replacement therapy (i.e., dialysis).\n\n    Angiographic Exclusion Criteria:\n14. Presence of a previously placed intravascular stent in the target vessel or ipsilateral CCA.\n15. A significant CCA inflow or distal\u002Fintracranial lesion.\n16. Occlusion (TICI 0) or \"string sign\" \\> 1 cm of the ipsilateral common or internal carotid artery.\n17. An intraluminal filling defect consistent with thrombus.\n18. Presence of extensive or diffuse atherosclerotic disease involving the aortic arch or proximal common carotid artery that would preclude the safe introduction of the study device.\n19. Cerebral aneurysm, symptomatic or \\> 5 mm or AVM (arteriovenous malformation) of the cerebral vasculature.\n20. Massive exophytic (mushroom-like) or irregular endoluminal calcification seen on CTA or fluoroscopy.\n21. Failure to successfully cross the guidewire across the target lesion; successful crossing defined as tip of the guidewire distal to the target lesion.\n22. Type III or Bovine aortic arch anatomy.\n23. Angulation or tortuosity (≥ 90 degree) of the innominate and common carotid artery (CCA) that precludes safe, expeditious sheath placement or that will transmit a severe loop to the internal carotid after sheath placement.",{"count":175,"type":20},185,[90],"Prospective, Multi-center, Single-arm Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Femoral stenting (SKYWARD Trans-Femoral IDE Study)",[179,24],"Carotid Artery Calcification",[181,182,183],"IVL","Calcification","Carotid Calcification","2026-03-30",{"date":186,"type":31},"2026-04-06",{"date":188,"type":20},"2026-07",{"date":190,"type":20},"2032-12",{"name":192,"class":38},"Shockwave Medical, Inc.",{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":51,"phases":201,"briefSummary":202,"conditions":203,"keywords":204,"overallStatus":156,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":4},"100597744","study-of-the-shockwave-medical-skyrunner-carotid-intravascular-lithotripsy-ivl-system-for-the-treatment-of-calcified-carotid-arteries-prior-to-trans-carotid-stenting-skyward-trans-carotid-ide-investigational-device-exemption-study-100597744","NCT07062471","Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Carotid Stenting (SKYWARD Trans-Carotid IDE [Investigational Device Exemption] Study)","Prospective, Multi-center, Single-arm Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Carotid Stenting (SKYWARD Trans-Carotid IDE Study)","General Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Patient is able and willing to comply with all assessments in the study.\n3. Patient has been informed of the nature of the study, agrees to participate and has signed the approved informed consent form.\n4. Patient approved for inclusion by a Patient Screening Committee.\n5. Patient must have a life expectancy \\> 1 year at the time of the index procedure, in the opinion of the investigator at the time of enrollment, with no planned major cardiac intervention or surgery within 30 days following the index procedure.\n\n   Angiographic Inclusion Criteria:\n6. Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the carotid bifurcation.\n7. Target lesion must meet all requirements for commercially available trans-carotid stent systems (refer to IFU for requirements) and investigator intends to treat the target lesion with a single stent.\n8. Patient must meet one of the following criteria regarding neurological symptom status and degree of stenosis by duplex ultrasound in combination with CT or MR angiography:\n\n   1. Symptomatic: ≥ 50% stenosis of the internal carotid artery and the patient has a history of stroke, TIA and\u002For amaurosis fugax within 180 days of the procedure ipsilateral to the carotid artery to be treated.\n\n      OR\n   2. Asymptomatic: ≥ 70% stenosis of the internal carotid artery without any neurological symptoms.\n9. Patient has evidence of circumferential calcification of the stenotic lesion defined as ≥ 3 mm thickness of calcification as determined by Computed Tomography Angiography (CTA). MR angiography may be used in place of CTA for patients with a relative or absolute contraindication to CTA.\n10. Patient is high risk for CEA defined as meeting at least one anatomic or clinical high-risk condition listed below:\n\nAnatomic High Risk Inclusion Criteria:\n\n* Contralateral Carotid artery occlusion.\n* Tandem Stenoses \\> 70%.\n* High cervical carotid artery stenosis.\n* Restenosis after carotid endarterectomy.\n* Bilateral carotid artery stenosis requiring treatment within 30 days after index treatment.\n* Hostile neck anatomy but which the Investigator deems safe for trans- carotid access including but not limited to:\n\n  * Prior neck irradiation\n  * Radical neck dissection\n  * Cervical spine immobility\n\nClinical High Risk Inclusion Criteria:\n\n* Patient is ≥ 70 years of age.\n* Patient has congestive heart failure (CHF) - New York Heart Association (NYHA) Functional Class III or IV.\n* Patient has severe pulmonary disease (COPD) with either FEV \\\u003C 50% predicted or chronic oxygen therapy or resting PO2 of \\\u003C 60 mmHg (room air).\n* Patient has a history of angina Canadian Cardiovascular Society (CCS) class 3 or 4 or unstable angina.\n* Patient has known severe left ventricular dysfunction LVEF \\\u003C 30%.\n* Patient had a myocardial infarction \\> 72 hours and \\\u003C 6 weeks prior to procedure.\n* Coronary artery disease with two or more vessels with ≥ 70% stenosis.\n* Planned coronary artery bypass grafting (CABG) or valve replacement surgery between 31 and 60 days after index procedure.\n* Patient has permanent contralateral cranial nerve injury\u002Fparalysis.\n* Patient has chronic renal insufficiency (serum creatinine ≥ 2.5 mg\u002FdL). Note that patients on dialysis are excluded from study consideration per exclusionary criterion #16.\n* Planned abdominal aortic aneurysm repair or peripheral vascular surgery between 31 to 60 days after index procedure.\n\nGeneral Exclusion Criteria:\n\n1. Patient has alternative source of cerebral embolus, including but not limited to:\n\n   1. a history of chronic atrial flutter or atrial fibrillation, or paroxysmal atrial flutter or atrial fibrillation requiring chronic anticoagulation\n   2. knowledge of cardiac sources of emboli (e.g., left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, hemodynamically significant aortic stenosis, endocarditis, mitral stenosis, or left atrial myxoma)\n   3. recently (\\\u003C 60 days) replaced\u002Frepaired heart valve (either surgically or percutaneously).\n2. Patient has a history of spontaneous intracranial hemorrhage within the past 12 months, a hemorrhagic transformation of an ischemic stroke within the past 60 days or has had a recent stroke (\\\u003C 7 days) of sufficient size (on CT or MRI) to place the patient at risk of hemorrhagic conversion during the procedure.\n3. Patient with a history of major stroke with substantial neurological deficit (NIHSS ≥ 5 or mRS ≥ 3) within 1 month of index procedure.\n4. Patient has had a TIA, or amaurosis fugax within 48 hours prior to the procedure.\n5. Patient has neurologic illnesses within the past 2 years characterized by fleeting or fixed neurologic or cognitive deficit which cannot be distinguished from TIA or stroke.\n6. Patient has an intracranial tumor.\n7. Patient has an isolated hemisphere.\n8. Patient has an open stoma in the neck.\n9. Patient has an unresolved\u002Funcorrected bleeding disorder.\n10. Patient had a myocardial infarction (MI) within last 72 hours prior to index procedure.\n11. Patient has contralateral laryngeal, lateral recurrent, or vagus nerve injury.\n12. Patient has history of intolerance or allergic reaction to contrast material that cannot be adequately premedicated or to any of the required study medications (i.e., antiplatelet agents, statins) or device materials (refer to IFUs).\n13. Female patients who are pregnant, nursing, or may become pregnant.\n14. Patient is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached its primary endpoint.\n15. Patient has other medical, social, or psychological problems that, in the opinion of the investigator, would present difficulty in complying with protocol requirements.\n16. Patient is on renal replacement therapy (i.e., dialysis).\n\n    Angiographic Exclusion Criteria:\n17. Presence of a previously placed intravascular stent in the target vessel or ipsilateral CCA.\n18. A significant CCA inflow or distal\u002Fintracranial lesion.\n19. Occlusion (TICI 0) or \"string sign\" \\> 1 cm of the ipsilateral common or internal carotid artery.\n20. An intraluminal filling defect consistent with thrombus.\n21. CCA disease that would preclude the use of TCAR per IFU.\n22. Presence of extensive or diffuse atherosclerotic disease involving the aortic arch or proximal common carotid artery that would preclude the safe introduction of the study device.\n23. Patient has \\\u003C 5 cm of distance between the clavicle and bifurcation, as assessed by duplex ultrasound.\n24. Cerebral aneurysm, symptomatic or \\> 5 mm or AVM (arteriovenous malformation) of the cerebral vasculature.\n25. Massive exophytic (mushroom-like) or irregular endoluminal calcification seen on CTA or fluoroscopy.\n26. Failure to successfully cross the guidewire across the target lesion; successful crossing defined as tip of the guidewire distal to the target lesion.",{"count":175,"type":20},[90],"Prospective, Multi-center, Single-arm Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries prior to Trans-Carotid Stenting (SKYWARD Trans-Carotid IDE Study)",[179,24],[181,183,182],{"date":206,"type":31},"2026-04-03",{"date":208,"type":20},"2026-05",{"date":210,"type":20},"2032-10",{"name":192,"class":38},{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":216,"acronym":217,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":219,"enrollmentInfo":220,"targetDuration":222,"studyType":21,"phases":4,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":110},"100227622","the-crest-2-registry-100227622","NCT02240862","The CREST-2 Registry","C2R","Inclusion Criteria\n\nAsymptomatic patients:\n\nAge ≥ 18 and ≤ 80 and any one of the following\n\n1. ≥70% stenosis, standard surgical risk for CEA\n2. ≥70% stenosis, high anatomic risk for CEA\n3. ≥70% stenosis, high physiologic risk for CEA\n\nSymptomatic patients:\n\nSymptomatic patients are defined by the following characteristics: Ipsilateral carotid Transient Ischemic Attack (TIA), with neurologic symptoms persisting less than 24 hours; Ipsilateral non-disabling stroke: Modified Rankin Scale (mRS) ≤ 3; and Ipsilateral transient monocular blindness: amaurosis fugax. \\[Source: current Medicare NCD for CAS\\]\n\nAge ≥ 18 and ≤ 80 and any one of the following\n\n1. ≥50% stenosis, standard surgical risk for CEA\n2. 50% to 69% stenosis, high anatomic risk for CEA\n3. 50% to 69% stenosis, high physiologic risk\n4. ≥70% stenosis, high anatomic and\u002For physiologic risk for CEA - currently covered by Medicare, but sites are strongly encouraged to voluntarily include these patients in C2R\n5. ≥70% stenosis, post-CEA and -CAS - currently covered by Medicare, but sites are strongly encouraged to voluntarily include these patients in C2R\n6. ≥70% stenosis, post-irradiation - currently covered by Medicare, but sites are strongly encouraged to voluntarily include these patients in C2R\n\nExclusion Criteria:\n\nPatients with any one of the following conditions are ineligible for enrollment in C2R\n\n1. NYHA Class IV CHF\n2. COPD on chronic continuous oxygen therapy\n3. Severe (Class Childs D) liver failure\n4. End-stage renal failure requiring dialysis\n5. Cancer with metastatic spread and\u002For undergoing active chemotherapeutic treatment\n6. Any dementia considered greater than \"mild\"","80 Years",{"count":221,"type":20},8000,"12 Months","The objective of C2R is to promote the rapid initiation and completion of enrollment in the CREST-2 randomized clinical trial (clinicaltrials.gov ID NCT02089217). Patients with severe symptomatic and asymptomatic carotid artery occlusive disease will be treated with carotid artery stenting (CAS) performed by experienced and skilled interventionists. Interventionists' eligibility will be determined by a multi-specialty Interventional Management Committee (IMC). Patient eligibility will include patients with standard or high-risk, symptomatic or asymptomatic carotid artery disease. Patients will be followed for the occurrence of post-procedural complications. The primary safety and quality endpoint will be the occurrence of any stroke or death within the 30-day period following the stenting procedure. The safety and quality results from C2R will guide selection of interventionists for participation in the CREST-2 randomized clinical trial. Enrollment into C2R will begin in 2015 and continue until publication of the primary results of the randomized trial.",[24],"2026-02-16",{"date":227,"type":31},"2026-02-18",{"date":229,"type":31},"2015-02",{"date":231,"type":20},"2027-01-31",{"name":233,"class":77},"University of Maryland, Baltimore",{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":16,"minAge":240,"maxAge":219,"enrollmentInfo":241,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":243,"conditions":244,"keywords":248,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":110},"100500789","prediction-of-cerebral-hyperperfusion-syndrome-after-carotid-revascularization-using-deep-learning-100500789","NCT05800821","Prediction of Cerebral Hyperperfusion Syndrome After Carotid Revascularization Using Deep Learning","Inclusion Criteria:\n\n1. Age between 30 and 80 years.\n2. Occlusive-stenotic lesion of the carotid arteries with indications for carotid revascularization.\n\nExclusion Criteria:\n\n1. Systemic vasculitis.\n2. Cerebral vessel aneurysms.\n3. Arteriovenous malformation of the brain.\n4. Primary brain tumor (including metastatic lesions).\n5. Epilepsy.\n6. History of traumatic brain injury.\n7. Demyelinating diseases of the central nervous system.\n8. History of neuroinfection.\n9. Atrial fibrillation.\n10. Frequent supraventricular or ventricular extrasystoles.\n11. Chronic heart failure with left ventricular ejection fraction less than 40%.\n12. Chronic kidney disease with estimated glomerular filtration rate less than 45 mL\u002Fmin\u002F1.73 m².\n13. Presence of an implanted cardioverter-defibrillator or pacemaker.\n14. Presence of contraindications to the medical use of iodine-containing radiographic contrast agents.\n15. Patient's unwillingness to continue participating in the study.\n16. Absence of a temporal acoustic window for transcranial Doppler ultrasonography.","30 Years",{"count":242,"type":20},500,"Cerebral hyperperfusion syndrome (CHS) was initially described as a clinical complication following carotid endarterectomy (CEA), but it may occur after both CEA and carotid artery stenting. It is characterised by throbbing ipsilateral frontotemporal or periorbital headache, and sometimes diffuse headache, eye and facial pain, vomiting, confusion, macular oedema, visual disturbances, focal motor seizures with frequent secondary generalisation, focal neurological deficits, and intracerebral or subarachnoid haemorrhage.\n\nKnowledge of CHS among physicians remains limited. Most studies report an incidence of 1-3% after carotid endarterectomy. CHS is most common in patients with increases of more than 100% in cerebral perfusion compared with baseline after carotid revascularization, and is rare in patients with perfusion increases of less than 100% compared with baseline.\n\nThe pathophysiological mechanism of CHS is only partially understood. The chronic low-flow state induced by severe carotid disease results in compensatory dilation of cerebral vessels distal to the stenosis, as part of the normal autoregulatory response to maintain adequate cerebral blood flow (CBF). In this chronically dilated state, the vessels lose their ability to autoregulate vascular resistance in response to changes in blood pressure. Dysautoregulation has been shown to be proportional to the duration and severity of chronic hypoperfusion. After revascularization and reperfusion, impaired cerebral autoregulation may contribute to a cascade of intracranial microcirculatory changes, with an inability to respond adequately to the augmentation of CBF following carotid recanalization.\n\nAlthough most patients present with mild symptoms and signs, progression to severe and life-threatening complications can occur if CHS is not recognised and treated promptly. Because CHS is diagnosed on the basis of several non-specific signs and symptoms, patients may be misdiagnosed as having one of the better-known causes of perioperative complications, such as thromboembolism.",[24,245,246,247],"Carotid Atherosclerosis","Carotid Artery Stenosis","Cerebral Hyperperfusion Syndrome",[247,249,250,251],"Carotid Stenosis","Stroke","Deep Learning","2025-11-20",{"date":254,"type":31},"2025-11-25",{"date":256,"type":31},"2023-05-03",{"date":258,"type":20},"2030-05-03",{"name":260,"class":77},"State Institution \"Republican Scientific and Practical Center\" Cardiology, Belarus",{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":268,"targetDuration":4,"studyType":51,"phases":270,"briefSummary":271,"conditions":272,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":110},"100587146","study-on-the-trans-carotid-artery-occlusion-shunt-system-100587146","NCT06924593","Study on the Trans-Carotid Artery Occlusion Shunt System","Study on the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System for Carotid Artery Revascularization During Endovascular Treatment","Inclusion Criteria:\n\n* Age \\> 18 years;\n* For patients diagnosed with carotid artery stenosis and planned to undergo transcarotid artery endovascular revascularization, one of the following conditions must be met:\n\n  1. Symptomatic carotid artery stenosis: The degree of stenosis is determined by non-invasive imaging or angiography to be \\> 50%, and the patient has a history of stroke (mild or non-disabling), transient ischemic attack (TIA), and\u002For amaurosis fugax within 180 days before the operation.\n  2. Asymptomatic carotid artery stenosis: The degree of stenosis is determined by non-invasive imaging or angiography to be \\> 70%, and the patient has not experienced any neurological symptoms within 180 days before the operation.\n* The modified Rankin Scale (mRs) score ≤ 2 before enrollment.\n* The patient must meet at least one of the following important anatomical or comorbid high-risk conditions in order to be included in the study:\n\nAnatomical high-risk:\n\nA. Contralateral carotid artery occlusion; B. Presence of tandem stenosis in the internal carotid artery with a stenosis degree \\> 70%; C. Carotid artery stenosis above the C2 vertebral body; D. Restenosis after previous ipsilateral carotid endarterectomy; E. Bilateral carotid artery stenosis requiring treatment (treatment of the contralateral vessel should be carried out at least 30 days after the operation); F. \"Difficult neck\" suitable for the transcarotid approach as evaluated by the researcher, including but not limited to: history of previous neck radiotherapy, history of previous radical neck lymph node dissection, neck stoma or limited cervical spine mobility.\n\nComorbid high-risk:\n\nG. The patient's age is ≥ 70 years old; H. The patient has coronary artery disease involving \\> 2 vessels and has a history of angina pectoris of any severity; I. The patient has a history of angina pectoris, with Canadian Cardiovascular Society (CCS) angina class 3 or 4, or unstable angina pectoris (defined as resting angina pectoris accompanied by electrocardiogram changes); J. The patient has congestive heart failure (CHF) - New York Heart Association (NYHA) functional class 3 or 4; K. The patient is known to have severe left ventricular dysfunction with a left ventricular ejection fraction (LVEF) \\\u003C 30%; L. The patient has experienced a myocardial infarction within 72 hours to 6 weeks before the operation; M. The patient has severe pulmonary disease (chronic obstructive pulmonary disease, COPD), with a forced expiratory volume in one second (FEV1) \\\u003C 50% (predicted value), or has been receiving long-term oxygen therapy, or has an arterial partial pressure of oxygen (PO2) ≤ 60 mmHg (room air) at rest; N. The patient has permanent contralateral cranial nerve injury; O. The patient has chronic renal insufficiency (serum creatinine \\> 2.5 mg\u002FdL).\n\n* The diameter of the common carotid artery on the target lesion side is \\> 6 mm;\n* The patient is able to understand the purpose of the trial, voluntarily participates in this study, signs the informed consent form, and is willing to complete the follow-up according to the requirements of the protocol.\n\nExclusion Criteria:\n\n* Anatomical exclusion criteria:\n\nThere are extensive atherosclerotic plaques in the proximal part of the common carotid artery on the target lesion side, making the safe operation of the surgery difficult; There are lesions in the access area of the common carotid artery on the target lesion side and its proximal part towards the heart; The distance from the superior border of the clavicle on the target lesion side to the bifurcation of the common carotid artery is less than 5 cm; A stent or graft has been implanted in the carotid artery on the target lesion side; There are acute or subacute thrombosis, arteriovenous malformations at the target lesion or adjacent areas; Severe calcification or tortuosity at the target lesion site makes it difficult to deliver the instruments to the designated location; The target carotid artery is completely occluded;\n\n* Known to have uncontrollable hypertension (systolic blood pressure continuously ≥ 180 mmHg or diastolic blood pressure continuously ≥ 110 mmHg);\n* Combined with symptomatic severe stenosis of other blood vessels (including intracranial and extracranial vessels);\n* The patient has experienced an ischemic stroke within 3 months, and the stroke affects the evaluation of the endpoints;\n* There has been spontaneous intracranial hemorrhage within 12 months;\n* Carotid artery stenosis not caused by atherosclerosis (such as dissection, fibromuscular dysplasia, etc.);\n* There are other heart diseases that may lead to embolism: such as left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, artificial aortic valve or artificial mitral valve, calcific aortic stenosis, endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm or left atrial myxoma, etc.;\n* Severe dementia or other nervous system diseases that may interfere with the evaluation of neurological function;\n* Advanced heart failure;\n* Chronic atrial fibrillation; Paroxysmal atrial fibrillation with an episode within 6 months or paroxysmal atrial fibrillation requiring long-term anticoagulant therapy;\n* Myocardial infarction occurred within 72 hours before the operation;\n* Coronary artery bypass grafting (CABG), endovascular stent surgery, cardiac valve surgery or vascular surgical procedures have been or will be performed within 30 days before and after the operation;\n* There is an active bleeding tendency or severe coagulation dysfunction; There has been gastrointestinal bleeding within 30 days before the operation, which will affect antiplatelet therapy;\n* Hemoglobin (Hgb) \\\u003C 8 gm\u002FdL, platelet count \\\u003C 90×10\\^9\u002FL or a history of heparin-induced thrombocytopenia;\n* Patients with abnormal liver and kidney function before the operation \\[Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) exceeding 5 times the upper limit of the normal value; Serum creatinine (Cr) \\> 3.0mg\u002FdL (265.2μmol\u002FL) or end-stage renal disease receiving hemodialysis\\];\n* Patients known to be allergic to contrast agents, stent and delivery device materials (referring to nitinol, PTFE, nylon polymer materials); Patients known to have contraindications to anticoagulant and antiplatelet drugs;\n* Intracranial tumors or other malignant tumors;\n* Life expectancy is less than 1 year;\n* Women who plan to become pregnant, are pregnant or are breastfeeding;\n* Patients who are participating in other clinical trials at the same time and have not withdrawn from the trials;\n* Patients who are judged by the researcher as not suitable for participating in this clinical trial.",{"count":269,"type":20},162,[90],"The objective of the study is to evaluate the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System for Carotid Artery Revascularization during Endovascular Treatment",[273,246,24],"Revascularization","2025-08-04",{"date":276,"type":31},"2025-08-07",{"date":278,"type":31},"2025-06-30",{"date":280,"type":20},"2025-12-31",{"name":282,"class":77},"Shenzhen Wecan Medical Technology Co.,Ltd",{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":290,"enrollmentInfo":291,"targetDuration":4,"studyType":51,"phases":293,"briefSummary":294,"conditions":295,"keywords":296,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":309},"100566300","a-single-arm-pivotal-study-to-evaluate-acute-device-and-technical-success-of-the-cguard-prime-carotid-stent-system-when-used-in-conjunction-to-the-enroute-transcarotid-neuroprotection-system-in-patients-undergoing-carotid-artery-stenting-via-the-transcarotid-artery-revascularization-approach-100566300","NCT06653387","A Single-arm, Pivotal Study to Evaluate Acute Device and Technical Success of the CGuard Prime Carotid Stent System When Used in Conjunction to the ENROUTE Transcarotid Neuroprotection System in Patients Undergoing Carotid Artery Stenting Via the Transcarotid Artery Revascularization Approach","A Multicenter, Single-arm, Pivotal Study to Evaluate Acute Device and Technical Success of the CGuard Prime Carotid Stent System (80cm) When Used in Conjunction With the FDA-cleared ENROUTE Transcarotid Neuroprotection System (NPS) in Patients at High Risk for Adverse Events From Carotid Endarterectomy Undergoing Carotid Artery Stenting Via the Transcarotid Artery Revascularization (TCAR) Approach.","INCLUSION CRITERIA: Candidates for participation in the study must meet all of the following general inclusion criteria.\n\n* Patient is ≥ 18 years and \\\u003C 80 years of age.\n* Patient is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.\n* Patient is diagnosed with carotid artery disease treatable with a Carotid Artery Stent via a Transcarotid Artery Revascularization approach and is either symptomatic or asymptomatic, defined as:\n* Symptomatic carotid stenosis ≥ 50%. Symptomatic is defined as amaurosis fugax, transient ischemia attack (TIA) or stroke within the last 6 months ipsilateral to the side of the stenosis Or\n* Asymptomatic carotid stenosis ≥ 80%\n* High Risk condition for CEA: at least one, as shown below:\n\nComorbid conditions:\n\n* Age ≥ 70 (maximum 80 years)\n* CCS angina class 3-4 or unstable angina\n* Congestive Heart Failure (CHF) NYHA class III-IV\n* Left ventricular ejection fraction (LVEF) ≤ 35%\n* MI ≥ 72 hours and \\\u003C 6 weeks pre-procedure\n* Multi-vessel CAD (≥ 2 vessels \\>70% stenosis) and history of angina\n* Chronic Obstructive Pulmonary Disease (COPD) with FEV1\\\u003C50\n* Permanent contralateral cranial nerve injury\u002Fparalysis\n* Restenosis from previous carotid endarterectomy (CEA)\n* Planned coronary artery bypass grafting (CABG) or valve replacement surgery between 31-60 days after CAS\n* Abdominal aortic aneurysm surgical repair or Endovascular repair is planned between 31 to 60 days after CAS.\n\nAnatomic conditions:\n\n* Occlusion of the contralateral CCA or ICA.\n* Prior radiation treatment to the neck or a radical neck dissection.\n* Severe bilateral ICA stenosis requiring treatment.\n* Target lesion at or above the level of the jaw (C2) or below the clavicle.\n* Severe tandem lesions\n* Inability to extend the neck due to cervical disorders.\n* Laryngeal palsy or laryngectomy.\n* Prior head and neck surgery in the region of the carotid artery.\n* Tracheostomy or tracheostoma.\n* Spinal immobility of the neck.\n* Hostile neck or surgically inaccessible lesion.\n* Target vessel and lesion meet all requirements for the CGuard Prime™ 80 stent:\n* Target lesion location at the carotid bifurcation and\u002For proximal internal carotid artery (ICA)\n* The diameter at the stent landing zone is between 4.8 mm and 9.0 mm.\n* The target lesion length is ≤ 36 mm and can be covered by a single CGuard Prime™ 80 stent.\n* Patient must have a 5 cm long disease-free segment of the common carotid artery (CCA) measured from the clavicle to the carotid bifurcation, with a minimum vessel diameter of 6 mm suitable for vascular access, sheath insertion, and vessel clamping.\n\nEXCLUSION CRITERIA: Patients are not eligible for the study if they have any of the following exclusion criteria.\n\n* Patient had or will have an interventional procedure or surgery of the carotid, coronary or peripheral arteries within 30 days before or after the index carotid procedure.\n* Patient had or will have open heart surgery or valvular intervention (percutaneous or surgical), or any major operation, within 30 days before or after the index carotid procedure.\n* Vascular anatomy that would preclude safe sheath insertion or deliverability of stent\n* Patient had a previously placed stent in the ipsilateral ICA or CCA.\n* Total occlusion or presence of a \"string sign\" of the ipsilateral ICA or CCA.\n* Presence of a filling defect of the target lesion.\n* Tandem lesions, which cannot be covered by a single CGuard Prime™ stent.\n* Patient has a stenosis of the innominate artery or proximal CCA requiring revascularization\n* Patient has an open neck stoma.\n* Patient has a history of bleeding diatheses or coagulopathy.\n* Patient has hypercoagulable state.\n* Patient has an alternative source of cerebral embolus, including but not limited to:\n\n  1. Chronic atrial fibrillation.\n  2. Episode(s) of paroxysmal atrial fibrillation within the past 6 months or history of paroxysmal atrial fibrillation requiring chronic anticoagulation.\n  3. Knowledge of cardiac sources of embolus (e.g. left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcific aortic stenosis, endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma).\n  4. Recently (\\\u003C60 days) implanted heart valve (either surgically or endovascularly) as a known source of emboli as confirmed on echocardiogram,\n  5. Abnormal angiographic findings: ipsilateral intracranial or extracranial arterial stenosis (as determined by angiography or CTA\u002FMRA 6 months prior to index procedure) greater in severity than the lesion to be treated; cerebral aneurysm \\> 5mm; AVM (arteriovenous malformation) of the cerebral vasculature, or other abnormal angiographic findings.\n* Patient has a known sensitivity or allergy to nickel or titanium.\n* Patient has a sensitivity to contrast media that cannot be adequately pre-treated.\n* Patient has a sensitivity to both forms of protocol-acceptable anticoagulation strategies (i.e., both heparin AND Bivalirudin)\n* Patient has a sensitivity to an antiplatelet agent AND all protocol acceptable alternative antiplatelet options\n* Patient has a known intolerance to statins.\n* Patient has a life expectancy of less than 3 years from the date of enrollment as determined by the Wallaert Life Expectancy Scale\n* Patient has malignancy, primary or recurrent, and does not have independent assessment of life expectancy performed by the treating oncologist or an appropriate specialist other than the physician performing TCAR.\n* Patient has an evolving stroke or intracranial hemorrhage, or a history of previous intracranial hemorrhage or brain surgery within the past 12 months.\n* Patient had a recent stroke (≤ 7 days) placing him\u002Fher at risk of a hemorrhagic conversion during the index procedure.\n* Patient has a history of a major stroke with a neurologic deficit (NIHSS of ≥ 15 or mRS ≥3).\n* Patient had a TIA or amaurosis fugax or stroke within 48 hours of the index procedure.\n* Female patient who is pregnant or lactating or is planning to become pregnant.\n* Dementia or other neurologic condition that is likely to confound the neurologic assessment.\n* Clinical condition that, in the opinion of the investigator, makes endovascular therapy impossible or hazardous.\n* Patient has been previously enrolled in this clinical trial.\n* Patient is likely to be non-compliant with protocol-required follow up or medication in the opinion of the investigator.\n* Patient is currently participating in another clinical trial that has not completed its primary endpoint assessment or that may confound this study results.","79 Years",{"count":292,"type":20},50,[90],"The objective of this study is to evaluate acute device and technical success of the CGuard Prime™ Carotid Stent System (80cm) when used in conjunction with the Enroute NPS during Transcarotid Artery Revascularization procedures in the treatment of carotid artery stenosis in spatients at high risk for adverse events from carotid endarterectomy.",[24],[246,297,298,299],"Transcarotid Artery Revascularization","Carotid Artery Angioplasty","Stenting Procedure","2025-05-30",{"date":302,"type":31},"2025-05-31",{"date":304,"type":31},"2024-11-20",{"date":306,"type":20},"2027-11-20",{"name":308,"class":38},"InspireMD",8,{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":316,"eligibilityCriteria":317,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":51,"phases":320,"briefSummary":321,"conditions":322,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":110},"100587255","hemodynamic-monitoring-carotid-surgery-100587255","NCT06926010","Hemodynamic Monitoring Carotid Surgery","Effect of a Predictive Hemodynamic Approach on the Stump Pressure During Carotid Endoartectomy: a Randomized Controlled Trial","PREST","Inclusion Criteria:\n\n\\- \\>18 years old patients\n\nExclusion Criteria:\n\n* Body MassIndex \\> 35 Kg \u002Fm2;\n* Atrial Fibrillation\n* Urgent surgery\n* Pregnancy",{"count":319,"type":20},120,[90],"patients scheduled for carotid endoarterectomy will be randomly assigned to a group in which arterial hypotension will be avoided by a predictive haemodynamic approach or to a group in which arterial hypotension will be treated in a standard manner",[24,323],"Haemodynamic Monitoring","2025-05-14",{"date":326,"type":31},"2025-05-18",{"date":328,"type":31},"2025-04-10",{"date":330,"type":20},"2027-04",{"name":332,"class":77},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":51,"phases":342,"briefSummary":343,"conditions":344,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":110},"100589839","study-on-the-trans-carotid-artery-occlusion-shunt-system-combined-with-introducer-sets-100589839","NCT06959628","Study on the Trans-Carotid Artery Occlusion Shunt System Combined With Introducer Sets","Study on the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System Combined With Introducer Sets for Cerebral Protection During Carotid Angioplasty","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Patients with internal carotid artery stenosis, meeting at least one of the following conditions:\n* Asymptomatic carotid artery stenosis: Stenosis severity \\> 70%;\n* Symptomatic carotid artery stenosis: Stenosis severity \\> 50%, with one or more of the following symptoms occurring within 180 days prior to the procedure: transient ischemic attack (TIA), transient visual obscurations (TVO), or mild\u002Fnon-disabling stroke;\n* Common carotid artery diameter \\> 6 mm, and meets the required vascular diameter for carotid artery stenting;\n* The participant or their legal guardian is able to understand the purpose of the trial, voluntarily consent to participation, sign an informed consent form, and is willing to comply with follow-up requirements as outlined in the study protocol.\n\nExclusion Criteria:\n\n* Anatomical Exclusion Criteria:\n* Patients with extensive atherosclerotic plaques in the proximal common carotid artery, which hinder safe surgical manipulation;\n* Patients with lesions in the common carotid artery access area or its proximal segment;\n* Patients with the common carotid artery bifurcation located \\\u003C 5 cm from the clavicular margin;\n* Patients with tandem severe stenosis or occlusion at the target lesion site;\n* Patients who have previously received stent or graft implantation in the ipsilateral carotid artery;\n* Patients with bilateral carotid artery stenosis requiring intervention on both sides;\n* Patients with acute or subacute thrombosis, arteriovenous malformations, or other abnormal vascular structures in the target lesion or adjacent regions;\n* Patients with severe calcification or tortuosity at the target lesion site, making it difficult to deliver devices to the intended location;\n* Patients with concomitant severe symptomatic stenosis in other vascular territories, including intracranial or extracranial arteries;\n* Patients who have experienced an ischemic stroke within the past 3 months, which may impact endpoint evaluation;\n* Patients with a history of spontaneous intracranial hemorrhage within the past 12 months;\n* Patients diagnosed with carotid artery dissection;\n* Patients with carotid stenosis due to non-atherosclerotic causes;\n* Patients with other cardiovascular conditions that may predispose to embolism, including left ventricular aneurysm, cardiomyopathy, mechanical aortic or mitral valves, infective endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma;\n* Patients with central nervous system disorders, including cranial nerve impairment, which could confound endpoint evaluation (e.g., severe dementia, secondary epilepsy, etc.);\n* Patients with chronic atrial fibrillation;\n* Patients with paroxysmal atrial fibrillation episodes within the past 6 months or those requiring long-term anticoagulation therapy due to paroxysmal atrial fibrillation;\n* Patients who have had a myocardial infarction within the last 6 months;\n* Patients who have undergone or plan to undergo coronary artery bypass grafting (CABG), endovascular stenting procedures, or heart valve surgeries within 90 days prior to the procedure, which may interfere with endpoint evaluation;\n* Patients with active bleeding tendencies or significant coagulation disorders;\n* Patients with a history of gastrointestinal bleeding that could interfere with antiplatelet therapy;\n* Patients with preoperative liver or renal dysfunction, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels exceeding 5 times the upper limit of normal, or serum creatinine (Cr) \\> 3.0 mg\u002FdL (265.2 μmol\u002FL);\n* Patients with known hypersensitivity to contrast agents, anticoagulants, antiplatelet medications, or materials used in stent delivery systems (e.g., nitinol, PTFE, nylon-based polymers);\n* Patients with intracranial or other malignancies;\n* Patients with a life expectancy of less than 3 years;\n* Women who are planning pregnancy, pregnant, or breastfeeding;\n* Patients participating in another clinical trial or those who have not withdrawn or been excluded from a trial within the last 3 months of the screening period;\n* Other patients who, in the investigator's opinion, are deemed unsuitable for inclusion in the study",{"count":341,"type":20},15,[90],"The objective of the study is to evaluate the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System Combined with Introducer Sets for Cerebral Protection During Carotid Angioplasty",[246,24],"2025-04-28",{"date":347,"type":31},"2025-05-06",{"date":349,"type":31},"2024-07-01",{"date":351,"type":20},"2025-06-01",{"name":282,"class":77},{"id":354,"slug":355,"hasResults":11,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":361,"conditions":362,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":110},"100584327","biomarkers-and-unstable-carotid-plaque-100584327","NCT06887894","Biomarkers and Unstable Carotid Plaque","EVALUATION OF NEW BIOMARKERS IN THE IDENTIFICATION OF UNSTABLE CAROTID PLAQUE","Inclusion Criteria:\n\n* Presence of significant internal carotid artery stenosis referred to carotid artery endarterectomy.\n* Age\\>18 years\n\nExclusion Criteria:\n\n* Presence of significant internal carotid artery stenosis referred to carotid artery stenting",{"count":120,"type":20},"This prospective study investigated associations between circulating miRNAs and symptomatic and asymptomatic ICAS, carotid plaque morphology and future cardiovascular events.",[24],"2025-03-15",{"date":365,"type":31},"2025-03-20",{"date":367,"type":31},"2019-09-01",{"date":369,"type":20},"2027-12-31",{"name":332,"class":77},{"id":372,"slug":373,"hasResults":11,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":4,"eligibilityCriteria":377,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":378,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":379,"conditions":380,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":386,"locationsCount":110},"100583947","the-management-of-asymptomatic-carotid-stenosis-100583947","NCT06882954","The Management of Asymptomatic Carotid Stenosis","The Management of Asymptomatic Carotid Stenosis: Monocentric Experience","Inclusion Criteria:\n\n* Asymptomatic carotid stenosis\n* Patient with degree of carotid stenosis greater than 80% measured by the maximum systolic velocity at the site of the stenosis which must have been greater than 250 cm\u002Fs\n* Ultrasound characteristics of a possibly unstable plaque\n\nExclusion Criteria:\n\n* Symptomatic carotid artery stenosis",{"count":242,"type":20},"Carotid stenosis are asymptomatic if no hemispheric or retinal symptoms have appeared in the 6 months preceding the discovery of the stenosis. Asymptomatic carotid stenosis (ACS) accounts for about ¾ of all carotid lesions. The goal of treating carotid stenosis is to prevent a stroke. While carotid surgery is recommended in the elderly patients in cases of symptomatic carotid stenosis, that of ACS in patients over 75 years old, even when tight, remains subject to many controversies. Indeed, the debate, concerning the benefit to be expected from a surgical procedure or a possible angioplasty procedure, is not yet closed. The aim of our study, through a retrospective evaluation of the results of all consecutive carotid endarterectomy (CEA) and stenting in the participating center.",[24,249],{"date":382,"type":31},"2025-03-19",{"date":384,"type":31},"2019-01-01",{"date":369,"type":20},{"name":332,"class":77},{"id":388,"slug":389,"hasResults":11,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":393,"eligibilityCriteria":394,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":395,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":397,"conditions":398,"keywords":403,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":417},"100471247","carotid-intraplaque-neovascularization-combined-with-stress-echo-100471247","NCT05416385","Carotid Intraplaque Neovascularization Combined With Stress Echo","Combining Intraplaque Neovascularization With Risk Stratification by Carotid Stress ECHO","CIRCE","Inclusion Criteria:\n\n1. Men and women \\>18 years;\n2. Referred for a clinically indicated SE for assessment of ischemia and risk stratification;\n3. Able and willing to give informed consent.\n\nExclusion Criteria:\n\n1. Emergency procedure, or active acute coronary syndrome (active chest pain, ischemic electrocardiogram changes, or cardiac enzyme elevation);\n2. Referral for viability, pulmonary hypertension, or valve assessment;\n3. Referral outside of the normal working hours;\n4. History of significant CAD: percutaneous coronary intervention (PCI), coronary artery bypass graft (GABG), or coronary angioplasty;\n5. History of stroke or myocardial infarction (MI);\n6. Known or documented hypersensitivity or allergy to perflutren (DEFINITY® contrast agent);\n7. Known or documented allergy to Polyethylene Glycol (Peg) a component of DEFINITY®;\n8. History of carotid surgery (endarterectomy or stenting);\n9. Any serious medical condition or complication from the stress test that according to the investigator could interfere with the carotid scan or optimal care;\n10. Currently pregnant or breastfeeding;\n11. Previous enrolment into the study.",{"count":396,"type":20},1500,"The root cause of heart attacks and strokes is atherosclerosis, the hardening and thickening of blood vessels due to the presence of \"plaque\" which is a build-up of fat and cholesterol in the walls of vessels. To diagnose heart disease, patients receive a stress test to find out if they require surgery. Up to 52% of patients receiving an angiogram (surgery) to look at plaque blockages in the heart are found to be normal (no blockage). Patients who are suspected of having heart disease often undergo a stress test, which helps cardiologists decide if the patient has heart disease, but stress tests can give false results. In Ontario alone, 90% are stress tests are found to be normal and patients are sent home with little follow-up. Of these 3-5% (\\~4,000 patients\u002Fyear) will have a major cardiovascular event (heart attack, surgery, or death) within 3 years. We need to improve the stress test accuracy to reduce cardiac outcome. We now know that it is not just the total amount of plaque that leads to heart attacks and strokes, but the composition of the plaque that can lead to breakage causing a heart attack. Plaques are soft and fragile, and typically contain fat and small leaky blood vessels within their cores. If we are able to identify patients that have leaky plaques using ultrasound, we may be able to improve the accuracy of stress testing. We propose a study looking at the combination of stress testing (assessing heart function) and neck ultrasound (assessing plaque composition), to identify patients at risk for cardiovascular events (heart attacks and death). We will enrol patients from 6 sites across Canada and follow-them for cardiac outcome for 3 years.",[61,399,400,401,402,24],"Cardiovascular Diseases","Acute Coronary Syndrome","Ischemic Heart Disease","Myocardial Infarction",[404,405,406,407],"Ultrasound","Echocardiography","Stress Testing","Contrast Enhanced Ultrasound","2025-02-03",{"date":410,"type":31},"2025-02-06",{"date":412,"type":31},"2021-08-16",{"date":414,"type":20},"2026-08-16",{"name":416,"class":77},"Dr. Amer Johri",6,{"id":419,"slug":420,"hasResults":11,"nctId":421,"briefTitle":422,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":51,"phases":426,"briefSummary":427,"conditions":428,"keywords":430,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":435,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":110},"100312194","assessing-neurocognition-after-cerebrovascular-intervention-100312194","NCT03344276","Assessing Neurocognition After Cerebrovascular Intervention","Inclusion Criteria:\n\n* patients \\>18 years of age\n* ultrasound evidence of carotid stenosis; in which the patient has either 50% or greater symptomatic carotid stenosis or 70% or greater asymptomatic carotid stenosis.\n\nExclusion Criteria:\n\n1. patients \\\u003C18 years of age\n2. patients with without compatibility for MRI\n3. patients requiring carotid stenting for reasons not related to long-standing stenosis\n4. patients requiring emergency carotid stenting for acute symptoms such as crescendo transient ischemic attacks, intolerance of physiologic blood pressure.\n5. Patients that do not have appropriate capacity (i.e. understand the risks and benefits associated with this study) or are unable to consent for themselves will not be included in this study.",{"count":425,"type":20},20,[90],"Decreased blood flow to the brain can cause decreased cognitive function. Carotid disease can result in decreased blood flow to the brain. The investigators seek to assess this relationship prospectively through performing a battery of neurocognitive assessments, collection of serum markers of inflammation, and through neuroimaging at two points before intervention (2 months and 1 month before stenting) and at two points after intervention (1 month and 2 months after intervention). The goal is to provide prospective evidence to identify the extent to which carotid stenosis and hypoperfusion of the brain results in diminished neurocognitive performance, and see if serum biomarkers before and after stenting correlate with these findings.",[24,429],"Neurocognitive Dysfunction",[431,432,433,434],"carotid stenosis","neurocognition","carotid stenting","circle of willis",{"date":410,"type":31},{"date":437,"type":31},"2021-07-15",{"date":439,"type":20},"2025-12",{"name":441,"class":77},"University of California, San Diego",{"id":443,"slug":444,"hasResults":11,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":448,"eligibilityCriteria":449,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":51,"phases":452,"briefSummary":453,"conditions":454,"keywords":457,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":110},"100570206","stress-reduction-using-video-googles-on-patients-undergoing-vascular-surgery-100570206","NCT06704230","Stress Reduction Using Video Googles on Patients Undergoing Vascular Surgery","Multimedia Patient Entertainment During Vascular Surgery Procedures in Regional Anesthesia","MEP-VASC","Inclusion Criteria:\n\n* Planed carotid endarterectomy in local anesthesia\n\nExclusion Criteria:\n\n* patients which are not able to communicate because of stroke or language barrier,\n* Dementia or neurological damage which impairs answering questionnaires or the understanding of the situation during surgery\n* medication with steroids",{"count":451,"type":20},100,[90],"One treatment option of internal carotid artery stenosis is open surgical endarterectomy. The operation is frequently carried out under regional plexus anesthesia, allowing the patient to remain awake during the procedure. This approach offers the advantage of monitoring for neurological changes during carotid artery clamping, allowing the surgical team to immediately respond by placing a shunt to ensure cerebral perfusion. As a result, performing surgery under regional anesthesia provides therefor a benefit. However, for patients, the procedure, which can last up to two hours or longer in some cases, may pose a significant burden. The fixed position, inability to move, sterile drapes over the face, manipulation by the surgical team, and anxiety about potential complications are just a few of the factors that may distress patients during the operation. Increased sweating and reports of substantial subjective distress are not uncommon if the procedure is performed under local anesthesia.\n\nIn many medical fields, devices and therapies are now being utilized to reduce patient stress in the perioperative setting. In procedures performed under local or regional anesthesia, such as in orthopedics or dentistry, efforts are being made to make operations more tolerable and less stressful for patients. For example, music and video goggles are employed to entertain and distract patients during the intervention. Newer approaches using video googles appear in more and more fields to reduce distress. Especially in vascular surgery and particularly in carotid surgery, the use of audiovisual distraction during the procedure has not been implemented to our knowledge, and its benefits remain undocumented. Because of the special setting and burden for the patients it is highly necessary to test these devices in carotid surgery and explore potential benefits for these patients.",[24,455,456],"Regional Anesthesia","Distress, Procedural",[458,459,460,461],"video googles","carotid endarterectomy","distress in patients","vascular surgery","2024-11-22",{"date":464,"type":31},"2024-11-26",{"date":466,"type":31},"2022-09-09",{"date":468,"type":20},"2025-04",{"name":470,"class":77},"University Hospital Augsburg",{"id":472,"slug":473,"hasResults":11,"nctId":474,"briefTitle":475,"officialTitle":475,"acronym":476,"eligibilityCriteria":477,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":478,"enrollmentInfo":479,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":481,"conditions":482,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":110},"100556715","the-role-of-maintaining-external-carotid-artery-flow-in-graft-interposition-after-carotid-endarterectomy-100556715","NCT06528717","The Role of Maintaining External Carotid Artery Flow in Graft Interposition After Carotid Endarterectomy","AGICS","Inclusion Criteria:\n\n* symptomatic carotid stenosis (\\> 50%)\n* unilateral asymptomatic carotid stenosis (\\> 60%)\n* bilateral asymptomatic carotid stenosis (\\> 60%)\n\nExclusion Criteria:\n\n* carotid restenosis\n* \"major surgery\" in previous 6 months\n* previous brain trauma or surgery\n* malignant disease\n* epilepsy\n* carotid artery aneurysm","90 Years",{"count":480,"type":20},250,"Analyzing results of carotid graft interposition with and without flow preservation through external carotid artery after endarterectomy.",[24,250,245],"2024-07-25",{"date":485,"type":31},"2024-07-30",{"date":487,"type":31},"2024-06-12",{"date":489,"type":20},"2024-12-30",{"name":491,"class":77},"Institute for Cardiovascular Diseases Dedinje",{"id":493,"slug":494,"hasResults":11,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":4,"eligibilityCriteria":498,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":499,"enrollmentInfo":500,"targetDuration":4,"studyType":51,"phases":501,"briefSummary":504,"conditions":505,"keywords":508,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":110},"100179308","phase-1-multimodal-imaging-assessment-of-the-inflammatory-atheromatous-plaque-100179308","NCT01608516","Multimodal Imaging Assessment of the Inflammatory Atheromatous Plaque","Multimodal Assessment of the Inflammatory Atheromatous Plaque : Comparison Between 68Ga-NODAGA-RGD PET\u002FCT, 18F-FDG PET\u002FCT, MRI AND US","Inclusion Criteria:\n\n* age \\\u003C= 85 years\n* Karnofsky \\>= 80%\n* patient with indication ofr carotid endarterectomy\n* signed consent form\n\nExclusion Criteria:\n\n* indication for surgery other than endarterectomy \\\u003C14 days\n* contraindication to surgery\n* contraindication to MRI\n* contraindication to gadolinium injection (stage 4\u002F5 kidney insufficiency, GFR\\\u003C30ml\u002Fmin\u002F1.73m2)\n* pregnancy, breastfeeding\n* lack of discernment","85 Years",{"count":425,"type":20},[502,503],"PHASE1","PHASE2","The present study aims at assessing the ability of 68Ga-NODAGA-RGD PET\u002FCT for the detection of inflammatory atheromatous plaques in the carotid arteries, compared to 18F-FDG PET\u002FCT, MRI and US and to determine the contribution of each imaging technique. Current gold standard for inflammation is histopathology.\n\nHypothesis : 68Ga-NODAGA-RGD might give a better initial evaluation of patients with atheromatous plaques in the carotid artery eligible for endarterectomy.",[506,507,24],"Inflammation","Atheromatous Plaques",[509,510,511,512,513,514,515],"PET\u002FCT","68Ga-NODAGA-RGD","18F-FDG","MRI","US ultrasound","inflammatory atheromatous plaque","endarterectomy","2024-06-17",{"date":518,"type":31},"2024-06-20",{"date":520,"type":31},"2012-04",{"date":522,"type":20},"2024-12",{"name":524,"class":77},"University of Lausanne Hospitals",{"id":526,"slug":527,"hasResults":11,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":531,"eligibilityCriteria":532,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":533,"targetDuration":4,"studyType":51,"phases":535,"briefSummary":536,"conditions":537,"keywords":539,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":544,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":110},"100382580","endovascular-acute-stroke-intervention---tandem-occlusion-trial-100382580","NCT04261478","Endovascular Acute Stroke Intervention - Tandem OCclusion Trial","A Multi-centre, Prospective, Randomized, Open-label, Blinded Endpoint (PROBE) Controlled Trial Comparing Cervical Internal Carotid Artery Stenting to no Stenting During Thrombectomy for Tandem Occlusion Stroke","EASI-TOC","Inclusion Criteria:\n\n* Acute ischemic anterior circulation stroke eligible for endovascular therapy according to local guidelines, with or without prior intravenous thrombolysis:\n\n  * Occlusion of the carotid terminus, M1 or M2 segments of the middle cerebral artery (MCA)\n  * A neurological deficit judged to be disabling by the patient and\u002For treating physician\n  * Any acute imaging judged by the treating physician to demonstrate salvageable brain tissue possibly amenable to EVT\n  * Groin puncture within 24-hours of onset or last known normal\n* Tandem ipsilateral high-grade (≥70%) cervical internal carotid artery (ICA) stenosis or occlusion of presumed atherosclerotic etiology on initial non-invasive vascular imaging\n* Informed consent from patient or surrogate or deferral of consent, according to local ethics policies\n\nExclusion Criteria:\n\n* Pre-existing neurological impairment (modified Rankin score ≥3)\n* Any underlying disease or condition making protocol adherence and\u002For 3-month follow-up unlikely\n* Any known contra-indication to EVT, angioplasty\u002Fstenting, or antiplatelet therapy\n* Tandem ipsilateral high-grade (≥70%) cervical internal carotid artery (ICA) stenosis or occlusion NOT confirmed on conventional angiography\n* Ipsilateral ICA stenosis or occlusion attributable to clinically or radiologically confirmed arterial dissection\n* Isolated cervical carotid occlusion without intracranial occlusion\n* Pregnancy",{"count":534,"type":20},458,[90],"Patients with tandem occlusion or tandem lesion (TL), that is, stroke with an acute intracranial anterior circulation occlusion and an ipsilateral cervical ICA (c-ICA) high-grade stenosis or occlusion, constitute about 15-20% of patients undergoing endovascular thrombectomy (EVT).\n\nHowever, the optimal treatment of acute stroke patients with TL remains uncertain, as relatively few patients with TL were included in the major randomized controlled trials of EVT and management of the c-ICA was generally not specified by protocol nor analyzed post-hoc.\n\nRecent large multi-centre retrospective cases series suggest that acutely stented patients may have more favorable outcomes than patients treated with angioplasty alone or those with no acute ICA intervention, but high quality randomized trial data are lacking.\n\nEASI-TOC, a phase 3, academic multi-centre, controlled trial (PROBE design) with embedded pilot phase, will seek to determine if in patients undergoing acute intracranial thrombectomy for anterior circulation stroke with concurrent ipsilateral symptomatic high-grade (≥70%) atherosclerotic stenosis or occlusion of the extracranial ICA, endovascular ICA revascularization with stenting is superior to intracranial thrombectomy alone with regards to functional outcome at 90 days. Patients will be randomized to Acute stenting or No acute stenting (1:1 allocation).",[538,249,24],"Stroke, Acute",[540,541,542],"Thrombectomy","Tandem occlusion","Carotid stenting","2023-11-14",{"date":545,"type":31},"2023-11-18",{"date":547,"type":31},"2020-08-31",{"date":549,"type":20},"2027-03",{"name":551,"class":77},"Centre hospitalier de l'Université de Montréal (CHUM)",{"id":553,"slug":554,"hasResults":11,"nctId":555,"briefTitle":556,"officialTitle":556,"acronym":557,"eligibilityCriteria":558,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":499,"enrollmentInfo":559,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":560,"conditions":561,"keywords":564,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":110},"100480730","change-of-hemodynamics-and-cerebral-functions-after-carotid-artery-revascularization-100480730","NCT05539781","Change of Hemodynamics and Cerebral Functions After Carotid Artery Revascularization","HALO","Inclusion Criteria:\n\nInformed consent signed Patients with \\>=70% symptomatic or \\>=80% asymptomatic internal carotid stenosis\n\nExclusion Criteria:\n\nIncapability to give informed consent Previous disabling stroke Contralateral carotid occlusion or \\>70% stenosis Systemic disease judged non compatible with the procedures or randomization Suspected or manifested pregnancy General contraindications to MRI or CT studies",{"count":120,"type":20},"The majority (\\>80%) of strokes are of ischemic etiology, of which ≈15% to 20% are attributable to atherosclerosis of the extracranial carotid arteries. The primary goal in carotid artery revascularization is to prevent stroke in patients with carotid artery stenosis. Treatment options including carotid endarterectomy (CEA) and carotid artery stenting (CAS). Hence, the investigators aim to compare carotid artery stenting (CAS) with carotid endarterectomy (CEA) in terms of long-term prognostic endpoints. Also, CEA and CAS result in different postoperative geometric features of carotid arteries that entail relevant modifications of rheological parameters, that may be associated with the risk of local complications and carotid artery restenosis. Finally, long-term and sustained cognitive benefits after carotid artery revascularization need further research and evidence.",[24,246,562,399,563],"Cerebrovascular; Disorder, Arteriosclerotic","Nervous System Diseases",[459,433,565,566,567],"computational fluid dynamic","cognitive function","medical therapy","2022-09-13",{"date":570,"type":31},"2022-09-14",{"date":572,"type":31},"2020-01-01",{"date":574,"type":20},"2026-12-31",{"name":576,"class":77},"Beijing Friendship Hospital",{"id":578,"slug":579,"hasResults":11,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":583,"eligibilityCriteria":584,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":585,"targetDuration":4,"studyType":51,"phases":587,"briefSummary":588,"conditions":589,"keywords":590,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":592,"lastUpdatePostDateStruct":593,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":598,"locationsCount":110},"100383313","micronet-covered-stent-system-for-stroke-prevention-in-all-comer-carotid-revascularization-100383313","NCT04271033","MicroNet-covered Stent System for Stroke Prevention in All Comer Carotid Revascularization","Long-term Outcomes of MicroNet-covered Stent Routine Use for Stroke Prevention in Symptomatic and Increased-risk Asymptomatic Carotid Stenosis Patients Requiring Revascularization by Neurovascular Team Decision: PARADIGM-EXTEND","PARADIGM-EXT","General Inclusion Criteria:\n\n* Patient \\> 18 years old qualified by NeuroVascular Team for carotid revascularization according to local standards of care\n* Signed informed consent\n* Agreement (routin un this group of patients) to clinical and ultrasonographis follow up.\n\nAngiographic Inclusion Criteria:\n\n* De-novo atherosclerotic lesions or neo-atherosclerosis\n* Symptomatic patients (history of transient ischemic attack, ischaemic stroke or amaurosis fugax within 6 months from index procedure) with index artery stenosis ≥50% assessed in angiography with NASCET method or\n* Asymptomatic patients with index artery stenosis ≥70-80% assessed in angiography with NASCET method\n\nGeneral Exclusion Criteria:\n\n* Lack of NeuroVascular Team agreement on carotid revascularization indication\n* Lack of signed informed consent\n* Estimated life expectancy less than 1 year\n* Chronic renal failure with serum creatinine level \\> 3.0 mg\u002FdL\n* Myocardial Infarction within 72 hours prior to index procedure.\n* Pregnant women\n* Diagnosed coagulopathies\n* History of contrast media allergy, not reacting to pharmacotherapy\n\nAngiographic Exclusion Criteria:\n\n* Index lesion occlusion\n* Common carotid artery stent protruding to aortic arch\n* Anatomical conditions restricting stent implantation\n* Significant common carotid artery stenosis proximal to index lesion (unless treated)",{"count":586,"type":20},550,[90],"All-comer study of unselected patients suitable for carotid artery revascularization to evaluate the feasibility, efficacy and safety of first line endovascular revasculariztion using MicroNet covered stent (CGuard™) in the treatment of consecutive symptomatic and increased-stroke-risk asymptomatic carotid lesions that require revascularization by Neurovascular Team decision.",[24],[591],"Stenting","2022-03-14",{"date":594,"type":31},"2022-03-29",{"date":596,"type":31},"2015-09-01",{"date":161,"type":20},{"name":599,"class":77},"John Paul II Hospital, Krakow"]