Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-27 @ 11:47 PM
Study NCT ID:
NCT07045194
Status:
RECRUITING
Last Update Posted:
2025-10-29
First Post:
2025-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtue® SAB in the Treatment of Coronary ISR Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 740}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2032-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-27', 'studyFirstSubmitDate': '2025-06-16', 'studyFirstSubmitQcDate': '2025-06-26', 'lastUpdatePostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target Lesion Failure (TLF) at 12 months', 'timeFrame': '12 months', 'description': 'Defined as a composite of cardiac death (CD), non-fatal target vessel myocardial infarction (MI) SCAI definition, and ischema-driven target lesion revascularization (TLR)'}], 'secondaryOutcomes': [{'measure': 'Target Lesion Failure (TLF) Comparison at 12 months', 'timeFrame': '12 months', 'description': 'Target Lesion Failure (TLF) at 12 months of subjects treated with Virtue® SAB compared to a PBA Performance Goal.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['In-Stent Restenosis'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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 \\<100% diameter stenosis, OR\n* Visually estimated stenosis ≥ 50% and \\< 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 \\< 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 \\< 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.'}, 'identificationModule': {'nctId': 'NCT07045194', 'briefTitle': 'Virtue® SAB in the Treatment of Coronary ISR Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Orchestra BioMed, Inc'}, 'officialTitle': '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).', 'orgStudyIdInfo': {'id': 'Protocol - 0072'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtue SAB', 'description': 'Coronary PCI, Sirolimus AngioInfusion Balloon (SAB)', 'interventionNames': ['Device: Virtue Sirolimus AngioInfusion Balloon']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AGENT™ DCB', 'description': 'Coronary Angioplasty, AGENT™ Paclitaxel Drug-Coated Balloon (DCB)', 'interventionNames': ['Device: AGENT™ Paclitaxel Drug-Coated Balloon']}], 'interventions': [{'name': 'Virtue Sirolimus AngioInfusion Balloon', 'type': 'DEVICE', 'description': 'Percutaneous Coronary Intervention', 'armGroupLabels': ['Virtue SAB']}, {'name': 'AGENT™ Paclitaxel Drug-Coated Balloon', 'type': 'DEVICE', 'description': 'Percutaneous Coronary Intervention', 'armGroupLabels': ['AGENT™ DCB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11576', 'city': 'Roslyn', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'E Haag', 'role': 'CONTACT'}], 'facility': 'St. Francis Hospital', 'geoPoint': {'lat': 40.79982, 'lon': -73.65096}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'T Buchtmann', 'role': 'CONTACT'}], 'facility': 'The Lindner Center for Research at Christ Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'centralContacts': [{'name': 'Hans-Peter Stoll, MD, PHD', 'role': 'CONTACT', 'email': 'hpstoll@orchestrabiomed.com', 'phone': '646-956-2161'}, {'name': 'Amy Berman, MPH', 'role': 'CONTACT', 'email': 'aberman@orchestrabiomed.com'}], 'overallOfficials': [{'name': 'Dean Kereiakes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lindner Center for Research at Christ Hospital'}, {'name': 'Allen Jeremias, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Francis Hospital & Heart Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orchestra BioMed, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}