[{"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":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"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":19,"type":20},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.",[25,26,27],"Coronary Arterial Disease (CAD)","In Stent Restenosis","Calcified Coronary Lesions","NOT_YET_RECRUITING","2026-06-10",{"date":31,"type":32},"2026-06-12","ACTUAL",{"date":34,"type":20},"2026-06",{"date":36,"type":20},"2027-06",{"name":38,"class":39},"Minneapolis Heart Institute Foundation","OTHER",{"id":41,"slug":4,"hasResults":10,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"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":49,"type":20},78,"INTERVENTIONAL",[52],"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",[55,25,27],"PCI",[57,58,59],"super high-pressure balloon","percutaneous coronary intervention","intravascular lithotripsy","RECRUITING","2026-03-06",{"date":63,"type":32},"2026-03-10",{"date":65,"type":32},"2025-09-01",{"date":67,"type":20},"2027-06-30",{"name":69,"class":39},"Nanjing First Hospital, Nanjing Medical University",3,""]