NCT07045194

Virtue® SAB in the Treatment of Coronary ISR Trial

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).

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 740 (estimated)
• Sponsor: Orchestra BioMed, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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).

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Virtue Sirolimus AngioInfusion Balloon	Percutaneous Coronary Intervention
DEVICE	AGENT™ Paclitaxel Drug-Coated Balloon	Percutaneous Coronary Intervention

Timeline

• Start date: 2025-10-20
• Primary completion: 2028-10-01
• Completion: 2032-10-01
• First posted: 2025-07-01
• Last updated: 2025-10-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study