[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intravascular-lithotripsy-rotational-atherectomy-ofdi\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intravascular-lithotripsy-rotational-atherectomy-ofdi":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,56],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":32,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100636493","overviewing-real-world-outcomes-to-boost-interventional-management-of-calcified-coronary-lesions-the-orobica-registry-100636493",false,"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.","ALL","18 Years",{"count":19,"type":20},3000,"ESTIMATED","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.",[25,26,27,28,29,30,31],"Coronary Artery Disease (CAD)","Calcific Coronary Arteriosclerosis","Intravascular Lithotripsy; Rotational Atherectomy; OFDI","Orbital Atherectomy","Optical Coherence Tomography (OCT)","Intravascular Ultrasound","Percutaneous Coronary Intervention",[33,34,35,36,37,38,39,40,41,42],"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":46,"type":47},"2026-05-06","ACTUAL",{"date":49,"type":20},"2026-06-30",{"date":51,"type":20},"2036-06-30",{"name":53,"class":54},"Papa Giovanni XXIII Hospital","OTHER",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":80,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":5},"100617275","optimal-strategy-to-correct-stent-underexpansion-in-resistant-lesions-100617275","NCT07316504","Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions","OSCAR","Inclusion criteria :\n\n* Patient who have undergone coronary angiography with ISR, defined as ≥50% reduction of the diameter of the intrastent lumen occurring ≥ 6 months after stent implantation\n* And with a suspicion of stent under-expansion on angiography, possibly assisted by a stent enhancement technique\n* The reference diameter of the target vessel must be ≥2.5 mm and ≤5.0 mm.\n* Coronary flow must be TIMI 3\n* Ability to cross the lesion with the OCT catheter (possibly after predilatation with a balloon up to 2 mm)\n* Patient affiliated to the French National Health Insurance\n\nExclusion criteria :\n\n* Heart failure with NYHA III or IV (or cardiogenic shock)\n* LVEF \\\u003C20%\n* Chronic renal failure with clearance \\\u003C30mL\u002Fmn according to CKD\n* Pregnant or breast-feeding women\n* Patient with a condition\u002Fcomorbidity that could reduce compliance with the protocol, including pre-specified study follow-up\n* Patient participating in another ongoing medical study evaluating a pharmacological or biological agent or medical device, unless authorized by the concomitant protocol.\n* Patient unable to tolerate double antiaggregation (i.e., aspirin and clopidogrel or prasugrel or ticagrelor) for at least 6 months.\n* Possible or defined thrombus (by angiography or endovascular imaging) in the target vessel.",{"count":64,"type":20},80,"INTERVENTIONAL",[67],"NA","Percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) accounts for 5-10% of PCI. ISR may be linked to mechanical complications mainly under-expansion (UE), neointimal hyperplasia and\u002For neoatherosclerosis. International guidelines recommends non-compliant and very-high-pressure balloons, which lead to sub-optimal angiographic and clinical results. Recently, observational studies have suggested the feasibility and safety of intravascular lithotripsy (IVL) in UE treatment. There are no prospective randomised controlled studies comparing intravascular lithotripsy with balloons in ISR with UE.",[70,71,72,73,74,75,76,29,27,77,78,25,79],"Coronary Angioplasty","Restenosis","Lithotripsy","Restenosis of Coronary Artery Stent","Angioplasty, Transluminal, Percutaneous Coronary","Percutaneous Coronary Intervention (PCI)","OCT Angiography","Intravascular Lithotripsy","Coronary Artery Disease","Coronary Stent Restenosis",[81,82,83,84,38,85,86],"restenosis","underexpansion","intrastent restenosis","randomized clinical trial","baloon PCI","Percutaneous coronary intervention","RECRUITING","2025-12-18",{"date":90,"type":47},"2026-01-05",{"date":92,"type":47},"2025-10-22",{"date":94,"type":20},"2031-09",{"name":96,"class":54},"University Hospital, Clermont-Ferrand"]