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Virtue® SAB in the Treatment of Coronary ISR Trial

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial sites expanded: 2 → 15 locations
    • Eligibility criteria revised
    v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Primary completion date: Sep 2028 to Oct 2028
    • Start date changed from estimate of Oct 2025 to Oct 20, 2025
    v3
  3. Lead sponsor: [Redacted] to Orchestra BioMed, Incv2 Show 5 more changesShow less
    • Trial status: Withheld to Not Yet Recruiting
    • Primary completion date: Sep 2028
    • Study completion date: Oct 2032
    • Start date: Oct 2025
    • Study title shortened, about 4 words
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT07045194
Lead Sponsor Orchestra BioMed, Inc
Conditions
(from sponsor)		 Coronary Artery Disease
Related terms Coronary Artery Disease
Enrollment 740 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov