Virtue® SAB in the Treatment of Coronary ISR Trial

Part of paid clinical trials in Gainesville, Florida.

Sponsor
Orchestra BioMed, Inc
Study ID
NCT07045194
Status
Recruiting
Apply to this trial

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

First listed
Jul 1, 2025
Start date
Oct 20, 2025
Status verified
Jul 2026
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 (15)

FacilityCityStateZIPSite coordinators
The Cardiac and Vascular InstituteGainesvilleFlorida32605
Carissa Fertil
Ascension Sacred HeartPensacolaFlorida32504
Jessica Flores
Ascension St. VincentIndianapolisIndiana46290
Jessica Green
Ascension Via Christi Saint FrancisWichitaKansas67214
Kristen Thomas
Ascension Saint Agnes Heart CareBaltimoreMaryland21229
Heather T Blubaugh
Corewell Health William Beaumont University HospitalRoyal OakMichigan48073
Rachel Wylie
St. Francis HospitalRoslynNew York11576
E Haag
Mission HospitalAshevilleNorth Carolina28801
Grace Raegan
The Lindner Center for Research at Christ HospitalCincinnatiOhio45219
T Buchtmann
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107
Elizabeth Robinson
WellSpan HealthYorkPennsylvania17403
Lori Slenker
Ascension St. Thomas HospitalNashvilleTennessee37236
Peiman Nebi
TriStar Centennial Medical CenterNashvilleTennessee37203
Amara Howard
Ascension Seton HaysKyleTexas78640
Abigail Alvarado
Ascension Columbia St. Mary's HospitalMilwaukeeWisconsin53226
Stephenee Supan

Find similar trials in Gainesville, FL

By research site
The Cardiac and Vascular Institute· Gainesville, FLAscension Sacred Heart· Pensacola, FLAscension St. Vincent· Indianapolis, INAscension Via Christi Saint Francis· Wichita, KSAscension Saint Agnes Heart Care· Baltimore, MDCorewell Health William Beaumont University Hospital· Royal Oak, MI

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