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Virtue® SAB in the Treatment of Coronary ISR Trial

NCT07045194 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 740

Last updated 2025-10-29

No results posted yet for this study

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).

Conditions

Interventions

DEVICE

Virtue Sirolimus AngioInfusion Balloon

Percutaneous Coronary Intervention

DEVICE

AGENT™ Paclitaxel Drug-Coated Balloon

Percutaneous Coronary Intervention

Sponsors & Collaborators

  • Orchestra BioMed, Inc

    lead INDUSTRY

Principal Investigators

  • Dean Kereiakes, MD · Lindner Center for Research at Christ Hospital

  • Allen Jeremias, MD · St. Francis Hospital & Heart Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-20
Primary Completion
2028-10-31
Completion
2032-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07045194 on ClinicalTrials.gov