Compares two balloon devices for narrowed coronary artery stents
Tests a sirolimus balloon against a paclitaxel balloon in adults with narrowed heart stents.
Plain-language title generated from the registry record
Registry title: Virtue® SAB in the Treatment of Coronary ISR Trial
Key facts
- Where
- Asheville, Atlanta, Baltimore, Cincinnati, Gainesville, Greenville, Hollywood, Indianapolis, Kyle, Milwaukee, Nashville, New York, Pensacola, Philadelphia, Phoenix, Roslyn, Royal Oak, Springfield, Tupelo, Wichita, and York, United StatesSee the 22 sites
Where in United States
- Mission HospitalAsheville, United StatesTaking people
- Emory University HospitalAtlanta, United StatesTaking people
- Ascension Saint Agnes Heart CareBaltimore, United StatesTaking people
- The Lindner Center for Research at Christ HospitalCincinnati, United StatesTaking people
- The Cardiac and Vascular InstituteGainesville, United StatesTaking people
- Prisma HealthGreenville, United StatesTaking people
- Memorial Regional HospitalHollywood, United StatesTaking people
- Ascension St. VincentIndianapolis, United StatesTaking people
- Ascension Seton HaysKyle, United StatesTaking people
- Ascension Columbia St. Mary's HospitalMilwaukee, United StatesTaking people
- Ascension St. Thomas HospitalNashville, United StatesTaking people
- TriStar Centennial Medical centerNashville, United StatesTaking people
- Icahn School of Medicine at Mount SinaiNew York, United StatesTaking people
- Ascension Sacred HeartPensacola, United StatesTaking people
- Thomas Jefferson UniversityPhiladelphia, United StatesTaking people
- Banner-University Medical Center PhoenixPhoenix, United StatesTaking people
- St. Francis HospitalRoslyn, United StatesTaking people
- Corewell Health William Beaumont University HospitalRoyal Oak, United StatesTaking people
- Baystate HealthSpringfield, United StatesTaking people
- Cardiology Associates of North MisssissippiTupelo, United StatesTaking people
- Ascension Via Christi Saint FrancisWichita, United StatesTaking people
- WellSpan HealthYork, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Orchestra BioMed, Inc
- Trial code
- NCT07045194
- Record updated
- 22 October 2026
- Original description
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).Read full original descriptionShow less
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).
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: 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; The target lesion has a reference vessel diameter ≥ 2.0 mm and ≤ 4.0 mm by visual assessment; The subject has only one critical ISR lesion in the target vessel; The subject may have one other critical lesion in a non-target vessel that must be treated before the Target Lesion (TL); 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; The target lesion must have one of the following:; Visually estimated stenosis of ≥ 70% and <100% diameter stenosis, OR; Visually estimated stenosis ≥ 50% and < 70% with one of the following:; abnormal fractional flow reserve (FFR) including Angio based FFR ≤ 0.80, or; abnormal instantaneous wave-free ratio (iFR) or resting full-cycle ratio (RFR) ≤ 0.89, or; abnormal stress or imaging stress test, or; ischemic symptoms referable to the target lesion; Involved in a NSTEMI or Acute Coronary Syndrome (ACS) event with decreasing enzymes; 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.
Exclusion: Subjects with STEMI < 72 hours prior to index procedure and those with NSTEMI who have increasing biomarkers within 12 hours of the index procedure; 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; A dissection in the target lesion requiring treatment with a stent post pre-dilatation; The target ISR lesion has more than two layers of previously placed stents; Subject has critical unprotected left main coronary artery disease; Subject has a left ventricular ejection fraction < 30% within 6 months; Subject was treated by PCI or another coronary intervention within the last 30 days; Planned PCI or CABG after the index procedure; Target lesion is located within a saphenous vein graft or an arterial graft; Thrombus is present in the target vessel; > 50% stenosis of an additional lesion proximal or clinically significant distal (>2.0mm RVD) to the target lesion.