Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07045194

Virtue® SAB in the Treatment of Coronary ISR Trial

Led by Orchestra BioMed, Inc · Updated on 2025-10-29

740

Participants Needed

2

Research Sites

362 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Virtue® SAB in the Treatment of Coronary ISR Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • In-stent restenosis in a lesion with one or two stent layers previously treated with drug-eluting or bare metal stents in a native coronary artery
  • Target lesion in a vessel with a reference diameter between 2.0 mm and 4.0 mm by visual assessment
  • Only one critical ISR lesion present
  • One other critical lesion in a non-target vessel allowed if treated before the target lesion
  • Target lesion length 64; 26 mm and fully coverable by one Virtue4 or AGENT2 balloon, with possible extension up to 5 mm beyond the stented length
  • Target lesion must have either 64; 70% but less than 100% stenosis or 64; 50% to less than 70% stenosis with abnormal fractional flow reserve, iFR, RFR, stress test, or ischemic symptoms related to the lesion
  • Involvement in a NSTEMI or Acute Coronary Syndrome event with decreasing enzymes
  • Target lesion successfully pre-treated with residual stenosis 64; 30% and TIMI grade 3 flow before randomization
Not Eligible

You will not qualify if you...

  • Left ventricular ejection fraction less than 30% within 6 months
  • PCI or other coronary intervention within the last 30 days
  • Planned PCI or coronary artery bypass grafting after the index procedure
  • STEMI within 72 hours prior to procedure or NSTEMI with increasing biomarkers within 12 hours prior to procedure
  • Previous treatment of target vessel restenosis other than balloon angioplasty in single-layer ISR; any treatment other than balloon angioplasty in double-layer ISR
  • Target lesion located in a saphenous vein graft or arterial graft
  • Presence of thrombus in target vessel
  • More than 50% stenosis of another lesion proximal or clinically significant distal to the target lesion
  • Dissection in target lesion requiring stent after pre-dilatation
  • Target ISR lesion with more than two layers of stents
  • Critical unprotected left main coronary artery disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

St. Francis Hospital

Roslyn, New York, United States, 11576

Actively Recruiting

2

The Lindner Center for Research at Christ Hospital

Cincinnati, Ohio, United States, 45219

Actively Recruiting

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Research Team

H

Hans-Peter Stoll, MD, PHD

CONTACT

A

Amy Berman, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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