What is this study trying to find out about coronary artery disease?

This study is comparing two balloon devices used in coronary artery procedures to see how well they treat in-stent restenosis, a narrowing inside stents. The research aims to understand which device provides better clinical outcomes for patients with this condition. Orchestra BioMed, Inc is leading this research.

Who may be eligible for this coronary artery disease clinical trial?

Adults aged 18 years or older with in-stent restenosis in a native coronary artery previously treated with stents may be eligible. The target lesion must meet specific size and severity criteria, and participants should not have had recent coronary interventions or severe heart function impairment. Please review eligibility criteria for more details.

Is there any cost to participate in this coronary artery disease clinical trial?

Study-related care, including the study devices and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID07045194

Comparison of Virtue Sirolimus AngioInfusion Balloon and AGENT Paclitaxel Drug-Coated Balloon for Treating Coronary Artery In-Stent Restenosis

Led by Orchestra BioMed, Inc · Updated on 2026-07-23

740

Participants Needed

Research Sites

208 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are conducting a prospective, multi-center, single-blind, randomized study to compare two devices for treating coronary artery in-stent restenosis ISR. The study aims to evaluate whether the Virtue4 Sirolimus AngioInfusion12 Balloon SAB performs no worse than the AGENT12 Paclitaxel Drug-Coated Balloon DCB in improving clinical outcomes for patients with ISR, a condition where narrowing occurs inside previously placed stents in coronary arteries. Participants will be randomly assigned to receive treatment with either the Virtue SAB device or the AGENT Paclitaxel DCB during a percutaneous coronary intervention PCI procedure. The study compares these two balloon devices in a parallel design, with patients undergoing angioplasty using one of the devices. Treatment is focused on a single critical ISR lesion in a native coronary artery, covering lesions with specific size and severity criteria. During the trial, participants will be monitored for clinical outcomes, especially target lesion failure TLF at 12 months after treatment. Researchers will assess treatment success and safety through follow-up visits, collecting relevant clinical data over time. The total study completion is planned by October 2032, with primary outcome assessment expected by October 2028.

CONDITIONS

Brief Title

Virtue® SAB in the Treatment of Coronary ISR Trial

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

In-stent restenosis in one or two stent layers in a lesion previously treated with drug-eluting or bare metal stents in a native coronary artery
Target lesion has a reference vessel diameter between 2.0 mm and 4.0 mm by visual assessment
Only one critical ISR lesion in the target vessel
May have one other critical lesion in a non-target vessel that must be treated before the target lesion
Target lesion length must be 26 mm or less and fully coverable by one Virtue or AGENT balloon
Target lesion must have either stenosis of 70% or more but less than 100%, or stenosis between 50% and 70% with additional evidence of abnormal flow or ischemic symptoms
Involved in a NSTEMI or Acute Coronary Syndrome event with decreasing enzymes
Target lesion must be pre-treated with residual stenosis 30% or less and TIMI grade flow of 3 before randomization

You will not qualify if you...

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

Research Team

Hans-Peter Stoll, MD, PHD

Amy Berman, MPH

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Comparison of Virtue Sirolimus AngioInfusion Balloon and AGENT Paclitaxel Drug-Coated Balloon for Treating Coronary Artery In-Stent Restenosis

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria