Study Title: A prospective, multi-center, single-blind, randomized (1:1), noninferiority 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).
PI/Lead Researcher: Amir Lotfi, MD
IRB#: BH26-081
NCT#: NCT07045194
Location: Baystate Medical Center
Primary Sponsor: Orchestra BioMed, Inc.
Purpose: The purpose of this study is to compare how well two device/drug combination products open a blocked area in a heart artery. Eligible participants will have follow-up visits via phone call for 5 years after the procedure.
Eligibility
Inclusion Criteria:
Received a Drug-Eluting (DES) or Bare Metal Stent (BMS) in a Percutaneous Coronary Intervention (PCI) over 30 days ago.
Exclusion Criteria:
Are currently receiving dialysis.
Have an intolerance to antiplatelet drugs, anticoagulants required for the procedure.
Dates and Time Commitment
Recruitment Status: Active
Active Date Opened to Enrollment/Recruitment: 08/27/2026
Trial Start Date: 08/27/2026 Trial Expire Date: 06/02/2027 Time Commitment: 5 years from the day of the procedure. All follow-up visits are conducted over the phone. These calls will be completed at 1 month, 6 months, 1 year, 2, years, 3 years, 4 years, and 5 years after your study treatment.
