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).
Orchestra BioMed, Inc
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).
Description
The Virtue® ISR trial is a prospective, multi-center, single-blind, randomized (1:1), non-inferiority study. The Virtue® Sirolimus AngioInfusion™ Balloon (SAB) will be compared to the AGENT Paclitaxel Drug-Coated Balloon (DCB) in the treatment of coronary artery in-stent restenosis (ISR).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * In-stent restenosis (one or two stent layers) in a lesion previously treated with drug- eluting (DES) or bare metal stents (BMS) in a native coronary artery. * The target lesion is in a vessel with a reference vessel diameter ≥ 2.0 mm and ≤ 4.0 mm by visual assessment. * The subject has only one critical ISR lesion. * The subject may have one other critical lesion in a non-target vessel that must be treated before the Target Lesion (TL). * Target lesion length must be ≤ 26 mm and must be completely coverable by only one Virtue® or AGENT™ balloon. The balloon can extend u…
Interventions
- DeviceVirtue Sirolimus AngioInfusion Balloon
Percutaneous Coronary Intervention
- DeviceAGENT™ Paclitaxel Drug-Coated Balloon
Percutaneous Coronary Intervention
Locations (2)
- St. Francis HospitalRoslyn, New York
- The Lindner Center for Research at Christ HospitalCincinnati, Ohio