[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596418":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":38,"locations":47,"responsibleParty":78,"collaborators":26,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":26,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":26,"enrollmentInfo":89,"targetDuration":26,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":50,"whyStopped":26,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Orchestra BioMed, Inc","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Virtue SAB","EXPERIMENTAL","Coronary PCI, Sirolimus AngioInfusion Balloon (SAB)",[13],"Device: Virtue Sirolimus AngioInfusion Balloon",{"label":15,"type":16,"description":17,"interventionNames":18},"AGENT™ DCB","ACTIVE_COMPARATOR","Coronary Angioplasty, AGENT™ Paclitaxel Drug-Coated Balloon (DCB)",[19],"Device: AGENT™ Paclitaxel Drug-Coated Balloon",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Virtue Sirolimus AngioInfusion Balloon","Percutaneous Coronary Intervention",[9],null,{"type":22,"name":28,"description":24,"armGroupLabels":29,"otherNames":26},"AGENT™ Paclitaxel Drug-Coated Balloon",[15],[31,35],{"name":32,"affiliation":33,"role":34},"Dean Kereiakes, MD","Lindner Center for Research at Christ Hospital","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":37,"role":34},"Allen Jeremias, MD","St. Francis Hospital & Heart Center",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":26,"email":43},"Hans-Peter Stoll, MD, PHD","CONTACT","646-956-2161","hpstoll@orchestrabiomed.com",{"name":45,"role":41,"phone":26,"phoneExt":26,"email":46},"Amy Berman, MPH","aberman@orchestrabiomed.com",[48,65],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"St. Francis Hospital","RECRUITING","Roslyn","New York","11576","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-73.65096,40.79982,{"lat":60,"lon":59},[63],{"name":64,"role":41,"phone":26,"phoneExt":26,"email":26},"E Haag",{"facility":66,"status":50,"city":67,"state":68,"zip":69,"country":54,"countryCode":55,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"The Lindner Center for Research at Christ Hospital","Cincinnati","Ohio","45219",{"type":57,"coordinates":71},[72,73],-84.51439,39.12711,{"lat":73,"lon":72},[76],{"name":77,"role":41,"phone":26,"phoneExt":26,"email":26},"T Buchtmann",{"type":79,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100596418","virtue-sab-in-the-treatment-of-coronary-isr-trial-100596418",false,"NCT07045194","Virtue® SAB in the Treatment of Coronary ISR Trial","A Prospective, Multi-center, Single-blind, Randomized (1:1), Non-inferiority Study Comparing Clinical Outcomes of the Virtue® Sirolimus AngioInfusion™ Balloon (SAB) to the AGENT™ Paclitaxel Drug-Coated Balloon (DCB) in the Treatment of Coronary Artery In-stent Restenosis (ISR).","Inclusion Criteria:\n\n* In-stent restenosis (one or two stent layers) in a lesion previously treated with drug- eluting (DES) or bare metal stents (BMS) in a native coronary artery.\n* The target lesion is in a vessel with a reference vessel diameter ≥ 2.0 mm and ≤ 4.0 mm by visual assessment.\n* The subject has only one critical ISR lesion.\n* The subject may have one other critical lesion in a non-target vessel that must be treated before the Target Lesion (TL).\n* Target lesion length must be ≤ 26 mm and must be completely coverable by only one Virtue® or AGENT™ balloon. The balloon can extend up to 5 mm proximal or distal beyond the edge of the target stented length.\n* The target lesion must have one of the following:\n* Visually estimated stenosis of ≥ 70% and \\\u003C100% diameter stenosis, OR\n* Visually estimated stenosis ≥ 50% and \\\u003C 70% with one of the following:\n* abnormal fractional flow reserve (FFR) including Angio based FFR ≤ 0.80, or;\n* abnormal instantaneous wave-free ratio (iFR) or resting full-cycle ratio (RFR) ≤ 0.89, or;\n* abnormal stress or imaging stress test, or;\n* ischemic symptoms referable to the target lesion\n* Involved in a NSTEMI or Acute Coronary Syndrome (ACS) event with decreasing enzymes\n* Target lesion must be successfully pre-treated according to standard of care with an achieved residual stenosis of ≤ 30% by visual estimate with TIMI grade flow of 3 prior to randomization.\n\nExclusion Criteria:\n\n* Subject has a left ventricular ejection fraction \\\u003C 30% within 6 months.\n* Subject was treated by PCI or another coronary intervention within the last 30 days.\n* Planned PCI or CABG after the index procedure.\n* Subjects with STEMI \\\u003C 72 hours prior to index procedure and those with NSTEMI who have increasing biomarkers within 12 hours of the index procedure.\n* If single-layer ISR, any previous treatment (other than balloon angioplasty alone) of the target vessel for restenosis. If double-layer ISR, any treatment (other than balloon angioplasty alone) of the double-layer ISR restenosis.\n* Target lesion is located within a saphenous vein graft or an arterial graft.\n* Thrombus is present in the target vessel.\n* \\> 50% stenosis of an additional lesion proximal or clinically significant distal (\\>2.0mm RVD) to the target lesion.\n* A dissection in the target lesion requiring treatment with a stent post pre-dilatation.\n* The target ISR lesion has more than two layers of previously placed stents.\n* Subject has critical unprotected left main coronary artery disease.","ALL","18 Years",{"count":90,"type":91},740,"ESTIMATED","INTERVENTIONAL",[94],"NA","A prospective, multi-center, single-blind, randomized (1:1), non-inferiority study comparing clinical outcomes of the Virtue® Sirolimus AngioInfusion™ Balloon (SAB) to the AGENT™ Paclitaxel Drug-Coated Balloon (DCB) in the treatment of coronary artery in-stent restenosis (ISR).",[97],"Coronary Artery Disease",[99],"In-Stent Restenosis","2025-10-27",{"date":102,"type":103},"2025-10-29","ACTUAL",{"date":105,"type":103},"2025-10-20",{"date":107,"type":91},"2032-10",{"name":5,"class":6},2]