[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stent-thrombosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stent-thrombosis":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,52,88,113,142,171,187,227],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100636249","polymer-free-sirolimus-eluting-stent-real-world-investigation-of-safety-and-outcomes-100636249",false,"NCT07563231","Polymer-free Sirolimus Eluting Stent: Real-world Investigation of Safety and Outcomes","POLARIS : POLymer-free Sirolimus Eluting Stent: Real-world Investigation of Safety and Outcomes","POLARIS","Inclusion Criteria:\n\n* Age \\>= 18 years at the time of the index procedure.\n* Percutaneous coronary intervention performed at Geneva University Hospitals between January 2021 and December 2025.\n* Implantation of at least one study device\n* Indication for PCI according to current European or American guidelines.\n* Able and willing to provide written informed consent.\n* Sufficient knowledge of French, German, English, or Italian to understand the patient information document.\n\nExclusion Criteria:\n\n* Documented refusal to participate in research through opt-out from general consent.\n* Inability to provide informed consent (cognitive impairment or other).\n* Inability to be contacted for informed consent (no valid contact information, or unreachable after three contact attempts).\n* Life expectancy less than 12 months due to non-cardiac comorbidities at the time of consent.\n* Participation in another clinical trial that would interfere with the endpoints of this registry.","ALL","18 Years",{"count":20,"type":21},300,"ESTIMATED","5 Years","OBSERVATIONAL","POLARIS is a prospective, single-centre, single-arm observational pilot registry evaluating the real-world safety and efficacy of the Focus np (Abluminus np, Concept Medical, Tampa, FL, USA) polymer-free sirolimus-eluting stent in consecutive adult patients undergoing percutaneous coronary intervention (PCI). The primary endpoint is target lesion failure (TLF) at 12 months, defined per Academic Research Consortium-2 (ARC-2) criteria as the device-oriented composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation. Patients treated since January 2021 will be retrospectively identified and prospectively consented, with follow-up through 5 years. The registry will provide the first Western clinical evidence on this CE-marked device and serve as a template for a future national Swiss multicentre registry.",[26,27,28,29,30],"Coronary Artery Disease","Acute Coronary Syndrome","Myocardial Infarction","Stent Thrombosis","Percutaneous Coronary Intervention",[32,33,34,35,36,37,38],"drug-eluting stent","polymer-free stent","sirolimus","percutaneous coronary intervention","target lesion failure","registry","real-world evidence","NOT_YET_RECRUITING","2026-06-05",{"date":42,"type":43},"2026-06-09","ACTUAL",{"date":45,"type":21},"2026-06",{"date":47,"type":21},"2036-06",{"name":49,"class":50},"Dorian Garin","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":73,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":51},"100539831","phase-4-atorvastatin-pretreatment-in-cerebrovascular-events-apices-after-flow-diverter-implantation-100539831","NCT06308952","Atorvastatin Pretreatment in Cerebrovascular Events (APICES) After Flow Diverter Implantation","Atorvastatin Pretreatment in Cerebrovascular Events (APICES) After Flow Diverter Implantation: Protocol of a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial","Inclusion criteria:\n\n1. Aged 18 to 75 years old, male or non-pregnant female;\n2. UIA diagnosed by CTA, MRA, or DSA;\n3. Maximal aneurysmal diameter between 3 and 25mm;\n4. Understands the nature of the procedure and provision of written informed consent;\n5. Indications for FD implantation with or without adjunctive coiling;\n6. Is willing to return to the investigational site for follow-up according to our protocol.\n\nExclusion criteria:\n\nPatients will be excluded if they meet any of the following criteria:\n\n1. Contraindications to atorvastatin treatment or known allergy to atorvastatin;\n2. Pregnancy or lactation;\n3. Presence of other vascular lesions (coronary artery disease, abdominal aortic aneurysm, intracranial atherosclerotic stenosis, arteriovenous malformation, dural arteriovenous fistula, Moyamoya disease, etc.);\n4. Prolonged statin therapy (≥30 days) or prior indications for atorvastatin therapy according to the Chinese guidelines for lipid management (2023) 21;\n5. Ruptured aneurysms or target aneurysm received previous operative or endovascular treatment;\n6. Patient currently using drugs that interact with atorvastatin metabolism (including transporter inhibitors, cyclosporine, protease inhibitors, other lipid-lowering medications (such as fibrates, ezetimibe, pcsk9 inhibitor, etc.), antacids, erythromycin, cytochrome P450 enzyme, colchicine, etc.);\n7. Patients diagnosed with multiple intracranial aneurysms who require treatment for two or more intracranial aneurysms within a one-year period;\n8. The target aneurysm is non-saccular (dissecting, fusiform, pseudo, infectious, etc.)\n9. Other situations that the researcher deems unsuitable for inclusion in the study (inability to receive anti-platelet or anticoagulant medication; allergy or contraindication for the use of FD alloy, history of life-threatening allergy to contrast dye, ect).\n10. Patient was determined that intravenous general anesthesia or general anesthesia with tracheal intubation could not be tolerated.\n11. Unwilling to be followed up or likely to have poor treatment compliance at initial screening;\n12. Life expectancy less than 3 years;\n13. Severe neurological deficit that renders the patient unable to live independently (modified Rankin score ≥4);\n14. Enrollment in another trial.\n\nWithdrawal criteria\n\nIn this trial, participants who have provided written informed consent but are unable to complete the entire study for any reason will be withdrawn. These circumstances include the following:\n\n1. The participants voluntarily quit the trial for various reasons;\n2. Occurrence of serious adverse events (SAEs). The study may be terminated by the participants, principal investigators, ethics committee, sponsor, or regulatory authorities based on ethical considerations;\n3. Early termination of the process based on the investigator's judgment in order to prevent development of severe complications;\n4. Significant deviation in implementation, or the subject failed to comply with the scheduled protocol;\n5. Miss the follow-up due to changes in working\u002Fliving places, or fortuitous accident (traffic accident, bone fracture, accidental death, ect.). Thus, close follow-up should be conducted to determine their relationship with the usage of FD and experimental drug;\n6. Flawed or absence of informed consents.","75 Years",{"count":61,"type":21},354,"INTERVENTIONAL",[64],"PHASE4","APICES trial is an investigator-initiated, multicenter, multicenter, randomized, double-blind, placebo-controlled clinical trial that plans to enroll 396 patients with a 1-year follow-up, including a neurovascular imaging examination \\[digital subtraction angiography (DSA), CT angiography (CTA) or magnetic resonance angiography (MRA)\\] at 6 months after index treatment. It was designed in compliance with the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines. The study was approved by the Ethics Committee of Zhujiang Hospital of South Medical University (2024-KY-032-02) and registered at ClinicalTrials.gov (NCT06308952). The participants will be recruited from twelve advanced stroke centers in China.",[67,68,69,70,29,71,72],"Cerebrovascular Event","Stent Stenosis","Ischemic Stroke","Hemorrhagic Stroke","Death, Brain","Endothelial Dysfunction",[74,75,76,77],"Atorvastatin","Intracranial aneurysm","Flow-diverter devices","Stroke","RECRUITING","2026-02-27",{"date":81,"type":43},"2026-03-03",{"date":83,"type":43},"2024-07-30",{"date":85,"type":21},"2027-12-31",{"name":87,"class":50},"Duan Chuanzhi",{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":98,"conditions":99,"keywords":100,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":51},"100569882","flow-patterns-and-stent-thrombosis-100569882","NCT06700018","Flow Patterns and Stent Thrombosis","Development of a Novel Method for Detailed Evaluation of Blood Flow Patterns in Stented Segments and Assessment of Their Role in Stent Thrombosis","TISIS registry","Inclusion Criteria:\n\n* Patients undergone OCT-guided percutaneous coronary intervention and implanted with a second-generation drug-eluting stent\n* Patients who have suffered thrombosis post-stent implantation\n\nExclusion Criteria:\n\n\\-",{"count":97,"type":21},120,"The goal of this observational study is to study the effect of haemodynamic forces on thrombus formation and identify haemodynamic markers that predict stent thrombosis events in patients who have undergone OCT-guided percutaneous coronary interventions.\n\nThe primary objective of the study is to examine the efficacy of blood flow patterns in predicting stent thrombosis. Researchers will compare the blood flow patterns of the stent thrombosis group with that of the control group to understand the influence of blood flow patterns on thrombus formation and progression.",[29],[101,102,103,104],"stent thrombosis","endothelial shear stress","optical coherence tomography","blood flow simulations","2026-02-26",{"date":79,"type":43},{"date":108,"type":43},"2024-04-01",{"date":110,"type":21},"2026-07-14",{"name":112,"class":50},"Queen Mary University of London",{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":119,"targetDuration":121,"studyType":23,"phases":4,"briefSummary":122,"conditions":123,"keywords":127,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":51},"100583795","mini-crush-or-controlled-balloon-crush-for-true-coronary-bifurcation-lesions-100583795","NCT06880978","Mini-Crush Or Controlled Balloon-Crush For True Coronary Bifurcation Lesions","Inclusion Criteria:\n\n* Aged \\>18\n* PCI with mini-crush or controlled balloon-crush\n* Complex coronary bifurcation lesion (Medina 0.1.1 and Medina 1.1.1)\n\nExclusion Criteria:\n\n* Non-complex bifurcation anatomy\n* Bail-out 2-stent (reverse mini-crush or reverse controlled balloon-crush)\n* ST-elevation myocardial infarction\n* Cardiogenic shock status\n* In-stent restenosis\n* A history of coronary artery bypass grafting\n* Implantation of bare-metal stent\n* End-stage hepatic or renal disease\n* \\\u003C1-year life expectancy",{"count":120,"type":21},400,"12 Months","The mini-crush technique is one of the leading 2-stent techniques frequently applied by interventional cardiologists to treat complex bifurcation lesions. In the last 20 years, many technical innovations and iterations of mini-crush technique have been developed, and it maintains its popularity among invasive cardiologists. Moreover, mini-crush and double kissing-crush techniques have been compared in terms of clinical results in both left main and non-left main coronary bifurcation patient populations and no significant difference was found. However, the most important challenges of the mini-crush technique are the rewiring and advancement of a 1:1 non-compliant side-branch balloon after the main branch stent has been implanted. These challenges usually necessitate the use of a low profile balloon or additional support maneuvers (such as anchor balloon). Recently, a novel modified mini-crush-crush technique (controlled balloon-crush) has been introduced to the literature and is one of the most up-to-date crush techniques. The main advantage of this technique over the contemporary mini-crush technique is that the side branch can be easily rewired and the 1:1 size non-compliant balloon can easily pass through the crushed stent structure in the ostial part of the side branch. The basic rationale of this is that the crushing of the side branch stent is done in a more controlled manner (by slowly deflation of the side branch stent balloon) and this causes less disruption of the stent cells. This prospective observational study aims to assess the procedural and 1-year clinical outcomes of the contemporary mini-crush and controlled balloon-crush (modified mini-crush) double stenting techniques in patients with true coronary bifurcation lesions.",[124,125,126,29,77],"Coronary Bifurcation Lesions","Death","Myocardial Infarction (MI)",[128,129,130,131],"Coronary bifurcation","death","revascularization","stenting","2025-03-17",{"date":134,"type":43},"2025-03-18",{"date":136,"type":43},"2025-03-03",{"date":138,"type":21},"2026-08-01",{"name":140,"class":141},"Istanbul Mehmet Akif Ersoy Educational and Training Hospital","OTHER_GOV",{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":149,"targetDuration":151,"studyType":23,"phases":4,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":51},"100521900","complex-registry---a-prospective-cohort-study-to-describe-the-management-and-outcomes-of-patients-presenting-with-complex-and-calcified-coronary-artery-disease-100521900","NCT06075602","COMPLEX Registry - a Prospective COhort Study to Describe the Management and Outcomes of Patients Presenting with CompLEX and Calcified Coronary Artery Disease","COMPLEX","Inclusion Criteria:\n\n* Subject \\>18 years of age\n* Individuals presenting with chronic, complex and\u002For calcified CAD and requiring PCI or CABG\n* Complex coronary artery disease \u002F lesions must include at least one of the following attributes:\n* Long and\u002F or heavily calcified coronary lesions\n* In-stent restenosis\n* Chronic total occlusions (CTO)\n* Left main lesions\n* Bifurcation lesions\n* Bypass graft lesions\n* Small vessel disease \u002F coronary microvascular dysfunction (e.g. not amenable to PCI)\n* Subjects must be willing to sign a patient informed consent (PIC) or must have signed the General Consent (GK).\n\nExclusion Criteria:\n\nThe presence of any one of the following exclusion criteria will lead to exclusion of the patient.\n\n* Patient is \\\u003C18 years of age\n* Patient unwilling or unable to provide informed consent\n* Patients with no complex and calcified CAD",{"count":150,"type":21},5000,"10 Years","The purpose of the COMPLEX Registry is to prospectively and retrospectively collect baseline, clinical and procedural data of patients who have undergone PCI or CABG for complex and\u002F or calcified chronic CAD, irrespective of clinical presentation as well as to prospectively collect data about their clinical outcomes. The outcomes will be compared in different clinical subgroups (e.g. PCI vs. CABG). The impact of current PCI techniques\u002F devices, but also CABG strategies in different clinical settings and coronary artery lesions on cardiovascular outcomes will be assessed.",[154,26,155,156,157,158,159,160,161,29],"Coronary Disease","Coronary Restenosis","Coronary Arteriosclerosis","Coronary Artery Calcification","Stable Chronic Angina","Angina Pectoris","Angina, Stable","Angina, Unstable","2024-10-27",{"date":164,"type":43},"2024-10-29",{"date":166,"type":43},"2021-11-01",{"date":168,"type":21},"2031-12-31",{"name":170,"class":50},"Luzerner Kantonsspital",{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":178,"targetDuration":151,"studyType":23,"phases":4,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":182,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":186,"locationsCount":51},"100438392","siroop-registry---a-prospective-registry-study-to-evaluate-the-outcomes-of-coronary-artery-disease-patients-treated-with-sirolimus-or-paclitaxel-eluting-balloon-catheters-100438392","NCT04988685","SIROOP Registry - A Prospective Registry Study to Evaluate the Outcomes of Coronary Artery Disease Patients Treated With SIROlimus Or Paclitaxel Eluting Balloon Catheters","SIROOP","Inclusion Criteria:\n\n* Subject \\>18 years of age\n* Patients with significant acute or chronic coronary de-novo lesions or ISR lesions requiring treatment using PCI\n* Treatment with at least one DCB (device choice at the operator's discretion) In case of a patient with lesions treated at different procedural time, lesions will be separately collected and documented\n* Subjects must be willing to sign a patient informed consent (PIC) or must have signed the General Consent (GK).\n\nExclusion Criteria:\n\n* Patient is \\\u003C18 years of age\n* Patient unwilling or unable to provide informed consent\n* pregnancy and lactation\n* Indication for surgical revascularization",{"count":179,"type":21},2000,"The purpose of the SIROOP Registry is to retrospectively and prospectively collect baseline, clinical and procedural characteristics of patients who have undergone PCI and are treated with either currently available sirolimus or paclitaxel coated DCBs (see Table 1), irrespective of clinical presentation as well as to prospectively collect data about their clinical outcomes. Outcomes will be compared in different clinical subgroups. The impact of current DCBs in different clinical settings and coronary artery lesions on cardiovascular outcomes will be assessed.",[154,26,155,156,157,158,159,160,161,29],{"date":164,"type":43},{"date":184,"type":43},"2021-06-01",{"date":168,"type":21},{"name":170,"class":50},{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":62,"phases":196,"briefSummary":197,"conditions":198,"keywords":205,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":226},"100396044","phase-4-what-is-the-optimal-antithrombotic-strategy-in-patients-with-atrial-fibrillation-undergoing-pci-100396044","NCT04436978","What is the Optimal Antithrombotic Strategy in Patients With Atrial Fibrillation Undergoing PCI?","What is the Optimal Antithrombotic Strategy in Patients With Atrial Fibrillation Having Acute Coronary Syndrome or Undergoing Percutaneous Coronary Intervention?","WOEST-3","Inclusion Criteria:\n\n1. Patients ≥ 18 years\n2. Undergoing successful PCI (either ACS or elective PCI)\n3. History of or newly diagnosed (\\\u003C72 hours after PCI\u002FACS) atrial fibrillation or flutter with a long-term (≥ 1 year) indication for OAC\n\nExclusion Criteria:\n\n1. Contra indication to edoxaban, aspirin or all P2Y12 inhibitors\n2. Current indication for OAC besides atrial fibrillation\u002Fflutter (e.g. venous thromboembolism)\n3. \\\u003C12 months after any stroke\n4. CHADSVASc score ≥7\n5. Moderate to severe mitral valve stenosis (AVA ≤1.5 cm2)\n6. Mechanical heart valve prosthesis\n7. Intracardiac thrombus or apical aneurysm requiring OAC\n8. Poor LV function (LVEF \\\u003C30%) with proven slow-flow\n9. History of intracranial haemorrhage\n10. Active bleeding on randomization\n11. History of intraocular, spinal, retroperitoneal, or traumatic intra-articular bleeding, unless the causative factor has been permanently resolved\n12. Recent (\\\u003C1 month) gastrointestinal haemorrhage, unless the causative factor has been permanently resolved.\n13. Known coagulopathy\n14. Severe anaemia requiring blood transfusion or thrombocytopenia \\\u003C50 × 109\u002FL\n15. BMI \\>40 or bariatric surgery\n16. Kidney failure (eGFR \\\u003C15)\n17. Active liver disease (ALT, ASP, AP \\>3x ULN or active hepatitis A, B or C)\n18. Active malignancy excluding non-melanoma skin cancer\n19. Life expectancy \\\u003C1 year\n20. Pregnancy or breast-feeding women",{"count":179,"type":21},[64],"The optimal antithrombotic management in patients with coronary artery disease (CAD) and concomitant atrial fibrillation (AF) is unknown. AF patients are treated with oral anticoagulation (OAC) to prevent ischemic stroke and systemic embolism and patients undergoing percutaneous coronary intervention (PCI) are treated with dual antiplatelet therapy (DAPT), i.e. aspirin plus P2Y12 inhibitor, to prevent stent thrombosis (ST) and myocardial infarction (MI). Patients with AF undergoing PCI were traditionally treated with triple antithrombotic therapy (TAT, i.e. OAC plus aspirin and P2Y12 inhibitor) to prevent ischemic complications. However, TAT doubles or even triples the risk of major bleeding complications. More recently, several clinical studies demonstrated that omitting aspirin, a strategy known as dual antithrombotic therapy (DAT) is safer compared to TAT with comparable efficacy.\n\nHowever, pooled evidence from recent meta-analyses suggests that patients treated with DAT are at increased risk of MI and ST. Insights from the AUGUSTUS trial showed that aspirin added to OAC and clopidogrel for 30 days, but not thereafter, resulted in fewer severe ischemic events. This finding emphasizes the relevance of early aspirin administration on ischemic benefit, also reflected in the current ESC guideline. However, because we consider the bleeding risk of TAT unacceptably high, we propose to use a short course of DAPT (omitting OAC for 1 month). There is evidence from the BRIDGE study that a short period of omitting OAC is safe in patients with AF. In this study, these patients are treated with DAPT, which also prevents stroke, albeit not as effective as OAC. This temporary interruption of OAC will allow aspirin treatment in the first month post-PCI where the risk of both bleeding and stent thrombosis is greatest.\n\nThe WOEST 3 trial is a multicentre, open-label, randomised controlled trial investigating the safety and efficacy of one month DAPT compared to guideline-directed therapy consisting of OAC and P2Y12 inhibitor combined with aspirin up to 30 days. We hypothesise that the use of short course DAPT is superior in bleeding and non-inferior in preventing ischemic events. The primary safety endpoint is major or clinically relevant non-major bleeding as defined by the ISTH at 6 weeks after PCI. The primary efficacy endpoint is a composite of all-cause death, myocardial infarction, stroke, systemic embolism, or stent thrombosis at 6 weeks after PCI.",[27,28,199,200,201,202,203,77,29,204,26],"Atrial Fibrillation","Atrial Flutter","STEMI - ST Elevation Myocardial Infarction","NSTEMI - Non-ST Segment Elevation MI","Bleeding","Embolism",[27,28,199,200,201,202,206,207,208,209,210,211,212,203,213,77,29,214,215,216],"Oral Anticoagulant","NOAC - Novel Oral Anticoagulant","DOAC - Direct Oral Anticoagulant","DAPT - Dual Antiplatelet Therapy","Antithrombotic Therapy","Dual Therapy","Triple Therapy","Thrombosis","Systemic Embolism","Percutaneous coronary intervention","Coronary artery disease","2023-12-14",{"date":219,"type":43},"2023-12-15",{"date":221,"type":43},"2023-01-11",{"date":223,"type":21},"2027-12-01",{"name":225,"class":50},"St. Antonius Hospital",20,{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":62,"phases":236,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":51},"100458054","copenhagen-mesenteric-stent-study---a-randomized-trial-of-stent-versus-covered-stent-treatment-for-chronic-mesenteric-ischemia-100458054","NCT05244629","Copenhagen Mesenteric Stent Study - A Randomized Trial of Stent Versus Covered Stent Treatment for Chronic Mesenteric Ischemia","COMESS","Inclusion Criteria:\n\n* Patients with symptomatic CMI of atherosclerotic or atherothrombotic etiology\n* Intended endovascular treatment\n* Symptoms consistent with CMI (pain, weight loss, diarrhea)\n* Significant ostial stenosis (\\>50%) of the superior mesenteric artery on CTA\n* Significant stenosis on angiography (\\>50% or \\>15mmHg pressure gradient)\n* Patients \\> 18 years\n\nExclusion Criteria:\n\n* No informed consent\n* Non atherosclerotic cause of MI\n* Acute mesenteric ischemia (AMI)\n* Signs of acute bowel ischemia, peritonitis, laparotomy, sepsis\n* Previous stent treatment in the superior mesenteric artery(ies)\n* Target artery lesions \\>4cm in length\n* Unable to cross lesion with guidewire\n* Non-significant stenosis angiographically\n* Pregnancy\n* Allergies to contrast media or stent materials",{"count":235,"type":21},98,[237],"NA","Chronic mesenteric ischemia (CMI) is often caused by narrowings in the arteries providing blood to the intestines. Endovascular stent placement is considered the preferred treatment for this condition. Guidelines increasingly support the use of so called covered stents (CS) in stead of bare stents (BMS) for this use but the level of evidence for this is limited. Using CS incur additional costs for healthcare short-term but may prevent recurrence of narrowing and symptoms postoperatively benefitting patients and healthcare.\n\nStudy Objective:\n\nTo evaluate the outcomes after stenting of mesenteric arteries using BMS or CS.\n\nStudy Outcome:\n\nPrimary stent patency 1 year after placement\n\nThe trial will also evaluate complications, how often stents need to be reoperated, Quality of Life (QoL) and reasons for subjects death\n\nMethod:\n\nThis is a so called prospective, randomized controlled trial comparing CS vs. BMS. This means that one patients have agrred to treatment they will be randomly selected for treatment with either CS or BMS . The stent metal structure is identical in the two implants and the only difference is the graft covering, making this study unique.\n\nThe study will also collect blood samples for a biobank that will be used to study markers of disease and how these effect treatment outcomes.\n\nAll patients referred to the Department of Vascular Surgery due to CMI are considered for inclusion if they havechronic symptoms consistent with CMI, significant stenosis or occlusion of the superior mesenteric artery and are \\> 18 years Subjects not able to provide informed consent or who have non atherosclerotic cause of CMI, signs of acute loss of blood flow to the intestines cannot participate. Previous stent treatment in the superior mesenteric artery, pregnancy, allergies to contrast or stent materials are also reasons for not being included in this trial.\n\nSide effects, risks and disadvantages for participants The risk for procedure-related complications is less than 5% and similar in both study groups. Most short-term complications are related to vascular access sites and consist of local bleeding and thrombosis. Other potential complications include impaired renal function due to contrast use, contrast allergy, arterial dissection and death.",[240,241,242,243,244,245,29,246,247,248],"Mesenteric Ischemia","Bowel; Ischemic","Superior Mesenteric Atherosclerosis","Mesenteric Artery Stenosis","Stent Restenosis","Stent Occlusion","Stent-Graft Stenosis","Stent-Graft Thrombosis","Stent-Graft Restenosis","2023-06-09",{"date":251,"type":43},"2023-06-12",{"date":253,"type":21},"2023-06",{"date":255,"type":21},"2029-08",{"name":257,"class":50},"Rigshospitalet, Denmark"]