Virtue® SAB in the Treatment of Coronary ISR Trial (NCT07045194)
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).
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: The Cardiac and Vascular Institute — Gainesville, Florida
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (15 Sites)
- The Cardiac and Vascular Institute — Gainesville, Florida
- Ascension Sacred Heart — Pensacola, Florida
- Ascension St. Vincent — Indianapolis, Indiana
- Ascension Via Christi Saint Francis — Wichita, Kansas
- Ascension Saint Agnes Heart Care — Baltimore, Maryland
- Corewell Health William Beaumont University Hospital — Royal Oak, Michigan
- St. Francis Hospital — Roslyn, New York
- Mission Hospital — Asheville, North Carolina
- The Lindner Center for Research at Christ Hospital — Cincinnati, Ohio
- Thomas Jefferson University — Philadelphia, Pennsylvania
- WellSpan Health — York, Pennsylvania
- TriStar Centennial Medical Center — Nashville, Tennessee
- Ascension St. Thomas Hospital — Nashville, Tennessee
- Ascension Seton Hays — Kyle, Texas
- Ascension Columbia St. Mary's Hospital — Milwaukee, Wisconsin
📞 Contact the Study Coordinator
Phone: (646) 956-2161
Email: hpstoll@orchestrabiomed.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Coronary Artery Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.