Virtue® SAB in the Treatment of Coronary ISR Trial

Part of paid clinical trials in Roslyn, New York.

Sponsor
Orchestra BioMed, Inc
Study ID
NCT07045194
Status
Recruiting
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Conditions

  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Virtue Sirolimus AngioInfusion Balloon — DEVICE
    Percutaneous Coronary Intervention
  • AGENT™ Paclitaxel Drug-Coated Balloon — DEVICE
    Percutaneous Coronary Intervention

Study Details

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).

Key Dates

Start date
Oct 20, 2025
Status verified
Oct 2025
Primary completion
Oct 31, 2028
Completion
Oct 31, 2032

Study Design

Enrollment
740 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Virtue SAB
    Coronary PCI, Sirolimus AngioInfusion Balloon (SAB)
  • Active Comparator: AGENT™ DCB
    Coronary Angioplasty, AGENT™ Paclitaxel Drug-Coated Balloon (DCB)

Primary Outcome Measure

Target Lesion Failure (TLF) at 12 months [ Time Frame: 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
St. Francis HospitalRoslynNew York11576
E Haag
The Lindner Center for Research at Christ HospitalCincinnatiOhio45219
T Buchtmann

Find similar trials in Roslyn, NY

By research site
St. Francis Hospital· Roslyn, NYThe Lindner Center for Research at Christ Hospital· Cincinnati, OH

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