[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intravascular-ultrasound\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intravascular-ultrasound":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,86],{"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":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100591350","intravascular-ultrasound-for-peripheral-artery-disease-revascularization-100591350",false,"NCT06979284","Intravascular Ultrasound for Peripheral Artery Disease Revascularization","Intravascular Ultrasound for Peripheral Artery Disease Revascularization: The CLARITY Randomized Controlled Trial","CLARITY","Inclusion Criteria:\n\n1. Patients presenting with lower extremity PAD manifesting as CLTI:\n\n   a. CLTI is defined as ischemic rest foot pain, nonhealing wounds, or gangrene present for at least two weeks and that is attributable to objectively proven arterial occlusive disease, compatible with Rutherford class 4, 5 or 6, with the following supporting hemodynamic criteria1: i. For ischemic rest pain (Rutherford category 4): Ankle systolic pressure \\\u003C 40mmHg, toe pressure \\\u003C 30mmHg, or flat-line transtarsal pulse volume recording, OR ii. For tissue loss (Rutherford category 5, 6): Ankle systolic pressure \\\u003C 60 mmHg, toe pressure of \\\u003C 40mmHg, or flat-line transtarsal volume recording, AND\n2. Scheduled to undergo percutaneous revascularization, AND\n3. Informed consent\n4. Imaging evidence of an obstructive or occluded lesion (\\> 70%) in the infraiguinal circulation (e.g. femoral, popliteal, or infrapopliteal circulation) using angiography, ultrasound, computed tomography, or magnetic resonance imaging.\n5. An infrapopliteal lesion must be located in the proximal 2\u002F3 of native infrapopliteal vessels, with a vessel diameter of \\> 2.5mm by investigator visual assessment.\n6. The distal margin of the most distal target lesion must be located \\> 10 cm proximal to the proximal margin on the ankle mortise. The vessel segment distal to the most distal target lesion must be patent all the way to the ankle, with no obstructive lesion (\\>50% stenosis).\n\nExclusion Criteria:\n\n1. The presence of anatomic or comorbid conditions or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the potential participant's ability to participate in the trial or to comply with the follow-up requirements.\n2. The presence of any medical conditions precluding percutaneous revascularization\n3. The subject has previously had or requires surgical revascularization involving the vessel containing the target lesion of the ipsilateral extremity.\n4. The subject is bedridden or unable to walk (with assistance is acceptable).\n5. Life expectancy \\\u003C 12 months\n6. Age \\\u003C 18 years\n7. Active vasculitis, Buerger's disease, or acute limb-threatening ischemia\n8. Planned above-ankle amputation of the index limb within four weeks of the index procedure.\n9. Obstructive supra-inguinal \"inflow\" (\\>70% stenosis) which is not planned to be treated during index procedure or within 30 days of the index procedure.\n10. The subject has had any amputation to the ipsilateral extremity other than the toe or forefoot, or the subject has had a major amputation to the contralateral extremity \\\u003C 1 year before the index procedure and is not independently walking.\n11. Extensive tissue loss that is salvageable only with complex foot reconstruction or non-traditional trans metatarsal amputations.\n\n    1. Osteomyelitis that extends proximal to the metatarsal heads\n    2. Gangrene involving the plantar skin of the forefoot, midfoot or heel\n    3. Deep ulcer or large shallow ulcer (\\> 3 cm) involving the plantar skin of the f forefoot, midfoot, or heel\n    4. Full-thickness heel ulcer\n    5. Any wound with calcaneal bone involvement\n    6. Wounds that would require flap coverage or complex wound management for large soft tissue defect\n    7. Full-thickness wounds on the dorsum of the foot with exposed tendon or bone.","ALL","18 Years",{"count":20,"type":21},772,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this study is to determine if IVUS use, as compared to angiography alone, prevent major adverse limb events (MALE) or binary restenosis (a greater than 50% re-narrowing of the treated artery) in adult patients who have CLTI and are undergoing percutaneous revascularization.",[27,28,29,30,31],"Peripheral Arterial Disease(PAD)","Chronic Limb Threatening Ischemia","Intravascular Ultrasound","Major Adverse Limb Events","Restenosis","RECRUITING","2026-06-04",{"date":35,"type":36},"2026-06-08","ACTUAL",{"date":38,"type":36},"2025-12-05",{"date":40,"type":21},"2030-10",{"name":42,"class":43},"Hamilton Health Sciences Corporation","OTHER",2,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":54,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":64,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100636493","overviewing-real-world-outcomes-to-boost-interventional-management-of-calcified-coronary-lesions-the-orobica-registry-100636493","NCT07566403","Overviewing Real-World Outcomes to Boost Interventional Management of CAlcified Coronary Lesions: the OROBICA Registry.","OROBICA","Inclusion Criteria:\n\n* Patients undergoing percutaneous coronary intervention (PCI) for severely calcified coronary lesions, angiographically defined as radiopacities noted without cardiac motion before contrast injection, generally involving both sides of the arterial wall.\n* Patients undergoing PCI for calcified coronary lesions with intracoronary optical coherence tomography (OCT) showing at least one of the following features:\n\n  * calcium arc ≥180°\n  * calcium thickness ≥0.3 mm\n  * calcium length ≥3 mm\n  * presence of calcified nodules\n* Patients undergoing PCI for calcified coronary lesions with intravascular ultrasound (IVUS) showing at least one of the following features:\n\n  * calcium arc ≥180°\n  * concentric or superficial calcium with extensive acoustic shadowing\n  * presence of calcified nodules\n\nExclusion Criteria:\n\n* Lack of availability of essential clinical or procedural data.\n* Refusal or withdrawal of informed consent for the prospective component of the registry, when applicable.\n* Exercise of the right to object to data processing, according to applicable data protection regulations.",{"count":53,"type":21},3000,"5 Years","OBSERVATIONAL","The OROBICA (Overviewing Real-World Outcomes to Boost Interventional Management of CAlcified Coronary Lesions) Registry is a multicenter, ambispective, real-world observational study designed to evaluate clinical, procedural, imaging, and economic outcomes of patients undergoing percutaneous coronary intervention (PCI) for severely calcified coronary artery disease.\n\nCoronary artery calcification represents one of the main determinants of procedural complexity and adverse outcomes in contemporary interventional cardiology. Despite the increasing availability of advanced calcium-modification technologies and intracoronary imaging techniques, evidence regarding the optimal treatment strategy in real-world clinical practice remains limited, particularly among high-risk and complex patients often underrepresented in randomized trials.\n\nThe OROBICA Registry aims to systematically collect longitudinal data from all-comer patients treated for severely calcified coronary lesions using contemporary PCI strategies, including intracoronary imaging guidance (IVUS\u002FOCT), rotational atherectomy, orbital atherectomy, intravascular lithotripsy, specialty balloons, and combined calcium-modification approaches.\n\nThe primary objective is to assess clinical and procedural outcomes, with particular focus on target vessel failure (TVF). Secondary and exploratory objectives include evaluation of procedural success, imaging findings, predictors of adverse outcomes, healthcare resource utilization, and economic impact associated with the treatment of calcified coronary lesions.\n\nThe registry is designed as a flexible research platform intended to support future hypothesis-generating analyses and provide real-world evidence to improve personalized management strategies for calcified coronary artery disease.",[58,59,60,61,62,29,63],"Coronary Artery Disease (CAD)","Calcific Coronary Arteriosclerosis","Intravascular Lithotripsy; Rotational Atherectomy; OFDI","Orbital Atherectomy","Optical Coherence Tomography (OCT)","Percutaneous Coronary Intervention",[65,66,67,68,69,70,71,72,73,74],"Coronary calcifications","coronary artery disease","percutaneous coronary intervention","intravascular imaging","atherectomy","intravascular lithotripsy","rotational atherectomy","orbital atherectomy","cutting balloon","target vessel failure","NOT_YET_RECRUITING","2026-05-04",{"date":78,"type":36},"2026-05-06",{"date":80,"type":21},"2026-06-30",{"date":82,"type":21},"2036-06-30",{"name":84,"class":43},"Papa Giovanni XXIII Hospital",1,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":97,"conditions":98,"keywords":102,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":85},"100565941","efficacy-and-safety-of-shortening-dual-antiplatelet-therapy-duration-with-ivus-guidance-in-pci-patients-100565941","NCT06648720","Efficacy and Safety of Shortening Dual Antiplatelet Therapy Duration with IVUS Guidance in PCI Patients","Efficacy and Safety of Shortening Dual Antiplatelet Therapy Duration with IVUS Guidance in PCI Patients: a Multicenter, Randomized Controlled Trial","SHORTDAPT","Inclusion Criteria:\n\n* Patients aged 18 years or older.\n* Patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES).\n* Patients with the following clinical indications for PCI:\n\n  * Unstable Angina: Prolonged chest pain at rest, new-onset angina within the past 2 months, or increasing frequency\u002Fseverity of angina attacks.\n  * Acute Myocardial Infarction (MI): With or without ST-elevation.\n  * Chronic Coronary Syndrome: Requiring coronary revascularization.\n* Patients who agree to participate and provide informed consent.\n\nExclusion Criteria:\n\n* Inability to Provide Informed Consent: Patients who are unable or unwilling to provide consent.\n* Neurological Complications: Stroke or any permanent neurological deficits within the last 3 months.\n* Coronary Artery Bypass Graft Surgery: History of CABG surgery.\n* Planned Surgery: Patients who have surgeries planned within the next 12 months.\n* Severe Chronic Kidney Disease: Patients with an estimated glomerular filtration rate (eGFR) of less than 20 ml\u002Fmin\u002F1.73 m² or patients on dialysis.\n* Chronic Anticoagulation Therapy: Patients requiring chronic oral anticoagulation (e.g., warfarin, DOACs) beyond DAPT.\n* Thrombocytopenia: Platelet count less than 100,000\u002Fmm³.\n* Contraindications to Antiplatelet Therapy: Allergy or intolerance to aspirin or P2Y12 inhibitors.\n* Liver Disease: Patients with cirrhosis or significant liver dysfunction.\n* Limited Life Expectancy: Patients with a life expectancy of less than 12 months due to other non-cardiac conditions.\n* Other Medical Conditions: Any condition that might interfere with adherence to the study protocol or follow-up schedule.",{"count":95,"type":21},3566,[24],"This study is designed to assess the efficacy and safety of de-escalating dual antiplatelet therapy (DAPT) at 1 month compared to the standard 12 months of therapy in patients undergoing percutaneous coronary intervention (PCI) guided by intravascular ultrasound (IVUS). The main outcomes measured will include major adverse cardiovascular and cerebrovascular events (NACCE), bleeding events, and target vessel failure (TVF). The goal is to evaluate whether a shorter duration of DAPT is non-inferior to the standard 12-month regimen in preventing ischemic events while reducing the incidence of bleeding.",[99,100,29,101],"Coronary Arterial Disease (CAD)","Percutaneous Coronary Intervention (PCI)","Dual Antiplatelet Therapy",[103,104,105,99],"Shortening DAPT duration","Intravascular Ultrasound (IVUS)","Percutaenous Coronary Intervention (PCI)","2024-10-16",{"date":108,"type":36},"2024-10-18",{"date":110,"type":21},"2025-03-01",{"date":112,"type":21},"2029-03-01",{"name":114,"class":43},"University Medical Center Ho Chi Minh City (UMC)"]