Clinical Trial

Virtue® SAB in the Treatment of Coronary ISR Trial

Recruiting
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Summary
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).
Protocol Amendment History 1 change
notable Trial sites expanded: 2 -> 15 locations 2026-07-24
Trial Details
NCT Number NCT07045194
Lead Sponsor Orchestra BioMed, Inc
Conditions Coronary Artery Disease
Enrollment 740 participants
Start Date 2025-10-20
Primary Completion 2028-10 (estimated)
Study Completion 2032-10 (estimated)
Updated on ClinicalTrials.gov 2026-07-23