[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596418":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":26,"studyPopulation":17,"armGroups":27,"interventions":40,"overallOfficials":49,"centralContacts":57,"locations":66,"responsibleParty":97,"collaborators":17,"id":99,"slug":17,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":17,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":17,"enrollmentInfo":107,"targetDuration":17,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":69,"whyStopped":17,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Orchestra BioMed, Inc","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Target Lesion Failure (TLF) at 12 months","Defined as a composite of cardiac death (CD), non-fatal target vessel myocardial infarction (MI) SCAI definition, and ischema-driven target lesion revascularization (TLR)","12 months",[14],{"measure":15,"description":16,"timeFrame":12},"Target Lesion Failure (TLF) Comparison at 12 months","Target Lesion Failure (TLF) at 12 months of subjects treated with Virtue® SAB compared to a PBA Performance Goal.",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":23,"maskingDescription":17,"whoMasked":24},"SINGLE",[25],"PARTICIPANT","The Virtue® ISR trial is a prospective, multi-center, single-blind, randomized (1:1), non-inferiority study. The Virtue® Sirolimus AngioInfusion™ Balloon (SAB) will be compared to the AGENT Paclitaxel Drug-Coated Balloon (DCB) in the treatment of coronary artery in-stent restenosis (ISR).",[28,34],{"label":29,"type":30,"description":31,"interventionNames":32},"Virtue SAB","EXPERIMENTAL","Coronary PCI, Sirolimus AngioInfusion Balloon (SAB)",[33],"Device: Virtue Sirolimus AngioInfusion Balloon",{"label":35,"type":36,"description":37,"interventionNames":38},"AGENT™ DCB","ACTIVE_COMPARATOR","Coronary Angioplasty, AGENT™ Paclitaxel Drug-Coated Balloon (DCB)",[39],"Device: AGENT™ Paclitaxel Drug-Coated Balloon",[41,46],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":17},"DEVICE","Virtue Sirolimus AngioInfusion Balloon","Percutaneous Coronary Intervention",[29],{"type":42,"name":47,"description":44,"armGroupLabels":48,"otherNames":17},"AGENT™ Paclitaxel Drug-Coated Balloon",[35],[50,54],{"name":51,"affiliation":52,"role":53},"Dean Kereiakes, MD","Lindner Center for Research at Christ Hospital","PRINCIPAL_INVESTIGATOR",{"name":55,"affiliation":56,"role":53},"Allen Jeremias, MD","St. Francis Hospital & Heart Center",[58,63],{"name":59,"role":60,"phone":61,"phoneExt":17,"email":62},"Hans-Peter Stoll, MD, PHD","CONTACT","646-956-2161","hpstoll@orchestrabiomed.com",{"name":64,"role":60,"phone":17,"phoneExt":17,"email":65},"Amy Berman, MPH","aberman@orchestrabiomed.com",[67,84],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"St. Francis Hospital","RECRUITING","Roslyn","New York","11576","United States","US",{"type":76,"coordinates":77},"Point",[78,79],-73.65096,40.79982,{"lat":79,"lon":78},[82],{"name":83,"role":60,"phone":17,"phoneExt":17,"email":17},"E Haag",{"facility":85,"status":69,"city":86,"state":87,"zip":88,"country":73,"countryCode":74,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"The Lindner Center for Research at Christ Hospital","Cincinnati","Ohio","45219",{"type":76,"coordinates":90},[91,92],-84.51439,39.12711,{"lat":92,"lon":91},[95],{"name":96,"role":60,"phone":17,"phoneExt":17,"email":17},"T Buchtmann",{"type":98,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","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":108,"type":109},740,"ESTIMATED","INTERVENTIONAL",[112],"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).",[115],"Coronary Artery Disease",[117],"In-Stent Restenosis","2025-10-27",{"date":120,"type":121},"2025-10-29","ACTUAL",{"date":123,"type":121},"2025-10-20",{"date":125,"type":109},"2032-10",{"name":5,"class":6},2]