Virtue® SAB in the Treatment of Coronary ISR Trial

Recruiting now · Not applicable

Conditions studied: Coronary Artery Disease

In brief

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).

Key facts

Study ID

NCT07045194

Run by

Orchestra BioMed, Inc

People needed

740

Starts

2025-10-20

Expected to finish

2032-10-01

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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.
• 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.
• 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.

Where it is running

• The Cardiac and Vascular Institute — Gainesville, Florida, United States (enrolling)
• Ascension Sacred Heart — Pensacola, Florida, United States (enrolling)
• Ascension St. Vincent — Indianapolis, Indiana, United States (enrolling)
• Ascension Via Christi Saint Francis — Wichita, Kansas, United States (enrolling)
• Ascension Saint Agnes Heart Care — Baltimore, Maryland, United States (enrolling)
• Corewell Health William Beaumont University Hospital — Royal Oak, Michigan, United States (enrolling)
• St. Francis Hospital — Roslyn, New York, United States (enrolling)
• Mission Hospital — Asheville, North Carolina, United States (enrolling)
• The Lindner Center for Research at Christ Hospital — Cincinnati, Ohio, United States (enrolling)
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States (enrolling)
• WellSpan Health — York, Pennsylvania, United States (enrolling)
• TriStar Centennial Medical Center — Nashville, Tennessee, United States (enrolling)
• Ascension St. Thomas Hospital — Nashville, Tennessee, United States (enrolling)
• Ascension Seton Hays — Kyle, Texas, United States (enrolling)
• Ascension Columbia St. Mary's Hospital — Milwaukee, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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