[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"calcified-coronary-lesions\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:calcified-coronary-lesions":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100642512","opn-balloon-for-safe-recanalization-of-calcified-coronary-lesions-100642512",false,"NCT07646444","OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions","OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions (OPEN-SAFE Registry)","OPEN-SAFE","Inclusion Criteria:\n\n* Age 18 years or older\n* Subjects who underwent a clinically indicated PCI procedure that involved at least one OPN balloon\n* Date range for data collection will be from February 1, 2023 to December 31, 2028\n\nExclusion Criteria:\n\n* Subjects who have opted out of being included in research related data collection","ALL","18 Years",{"count":20,"type":21},300,"ESTIMATED","1 Week","OBSERVATIONAL","The goal of the OPEN-SAFE registry is to describe the contemporary use and outcomes of SIS-OPN in North America.",[26,27,28],"Coronary Arterial Disease (CAD)","In Stent Restenosis","Calcified Coronary Lesions","NOT_YET_RECRUITING","2026-06-10",{"date":32,"type":33},"2026-06-12","ACTUAL",{"date":35,"type":21},"2026-06",{"date":37,"type":21},"2027-06",{"name":39,"class":40},"Minneapolis Heart Institute Foundation","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100600153","super-high-pressure-balloon-versus-intravascular-lithotripsy-to-prepare-severely-calcified-coronary-lesions-100600153","NCT07093788","Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions","Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions: a Randomized Controlled Trial (Shape)","Shape","Inclusion Criteria:\n\n* Age \\> 18 years and \\\u003C 80 years\n* Presented as asymptomatic angina, stable angina, unstable angina, prior myocardial infarction (MI), or non-ST-elevation myocardial infarction (NSTEMI).\n* Have an indication for drug-eluting stent (DES) implantation\n* Denovo coronary artery calcified lesions\n* Target lesion diameter stenosis ≥ 70%, or target lesion diameter stenosis between ≥ 50% and \\\u003C 70%, accompanied by evidence of myocardial ischemia(such as fractional flow reserve (FFR) ≤ 0.80 or minimal lumen area (MLA) ≤ 4.0 mm²).\n* Reference vessel diameter of the target vessel between 2.5 mm - 4.5 mm\n* Maximum calcium arc within the lesion ≥ 270⁰ assessed by optical coherence tomography (OCT) or intravascular ultrasound (IVUS)\n* Unsatisfactory lesion preparation with non-compliant balloon, defined as baseline diameter stenosis reduction of \\\u003C 30% under maximal inflation pressure.\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Presented as acute ST-segment elevation myocardial infarction (STEMI), cardiogenic shock and multiple organ failure\n* Presented as severe contrast agent allergy\n* Intolerant to dual antiplatelet therapy (DAPT) and\u002For anticoagulation therapy\n* Presented as active phase of autoimmune disease\n* Calcified nodules or eccentric calcification lesions\n* Failure to reach the target lesion with guidewires or catheters\n* Complex coronary bifurcation lesions\n* Target vessel thrombosis or aneurysm within 10 mm of the target lesion","80 Years",{"count":51,"type":21},78,"INTERVENTIONAL",[54],"NA","this trial aimed to evaluate the stent expansion through intravascular imaging (optical coherence tomography (OCT) \\& intravascular ultrasound (IVUS)) among individuals underwent different preparation techniques ,then comparing the efficacy and safety of super high-pressure balloon to IVL in severely calcified lesions",[57,26,28],"PCI",[59,60,61],"super high-pressure balloon","percutaneous coronary intervention","intravascular lithotripsy","RECRUITING","2026-03-06",{"date":65,"type":33},"2026-03-10",{"date":67,"type":33},"2025-09-01",{"date":69,"type":21},"2027-06-30",{"name":71,"class":40},"Nanjing First Hospital, Nanjing Medical University",3]