Recruiting

Sirolimus vs. Paclitaxel

Sponsor:

Orchestra BioMed, Inc

Code:

NCT07045194

Conditions

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Virtue Sirolimus AngioInfusion Balloon

AGENT™ Paclitaxel Drug-Coated Balloon

Study Details

Brief 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

Coronary Artery Disease

Study ID

NCT07045194

Start date

Oct 20, 2025

Status verified date

Jul, 2026

Completion date

Oct, 2032

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • In-stent restenosis (one or two stent layers) in a lesion previously treated with drug- eluting (DES) or bare metal stents (BMS) in a native coronary artery.
  • The target lesion has a reference vessel diameter ≥ 2.0 mm and ≤ 4.0 mm by visual assessment.
  • The subject has only one critical ISR lesion in the target vessel.
  • The subject may have one other critical lesion in a non-target vessel that must be treated before the Target Lesion (TL).
  • Target lesion length must be ≤ 26 mm and must be completely coverable by only one Virtue® or AGENT™ balloon. The balloon can extend up to 5 mm proximal or distal beyond the edge of the target stented length.
  • The target lesion must have one of the following:
  • Visually estimated stenosis of ≥ 70% and <100% diameter stenosis, OR
  • Visually estimated stenosis ≥ 50% and < 70% with one of the following:
  • abnormal fractional flow reserve (FFR) including Angio based FFR ≤ 0.80, or;
  • abnormal instantaneous wave-free ratio (iFR) or resting full-cycle ratio (RFR) ≤ 0.89, or;
  • abnormal stress or imaging stress test, or;
  • ischemic symptoms referable to the target lesion
  • Involved in a NSTEMI or Acute Coronary Syndrome (ACS) event with decreasing enzymes
  • Target lesion must be successfully pre-treated according to standard of care with an achieved residual stenosis of ≤ 30% by visual estimate with TIMI grade flow of 3 prior to randomization.

Exclusion Criteria:

  • Subject has a left ventricular ejection fraction < 30% within 6 months.
  • Subject was treated by PCI or another coronary intervention within the last 30 days.
  • Planned PCI or CABG after the index procedure.
  • Subjects with STEMI < 72 hours prior to index procedure and those with NSTEMI who have increasing biomarkers within 12 hours of the index procedure.
  • If single-layer ISR, any previous treatment (other than balloon angioplasty alone) of the target vessel for restenosis. If double-layer ISR, any treatment (other than balloon angioplasty alone) of the double-layer ISR restenosis.
  • Target lesion is located within a saphenous vein graft or an arterial graft.
  • Thrombus is present in the target vessel.
  • > 50% stenosis of an additional lesion proximal or clinically significant distal (>2.0mm RVD) to the target lesion.
  • A dissection in the target lesion requiring treatment with a stent post pre-dilatation.
  • The target ISR lesion has more than two layers of previously placed stents.
  • Subject has critical unprotected left main coronary artery disease.

Study Design

Enrollment

740 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Virtue SAB

Coronary PCI, Sirolimus AngioInfusion Balloon (SAB)

active comparator: AGENT™ DCB

Coronary Angioplasty, AGENT™ Paclitaxel Drug-Coated Balloon (DCB)

Interventions

Virtue Sirolimus AngioInfusion Balloon

Percutaneous Coronary Intervention

AGENT™ Paclitaxel Drug-Coated Balloon

Percutaneous Coronary Intervention

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Hans-Peter Stoll, MD, PHD

646-956-2161hpstoll@orchestrabiomed.com

Amy Berman, MPH

aberman@orchestrabiomed.com

Locations

The Cardiac and Vascular Institute

Recruiting

Gainesville, Florida, United States, 32605

Ascension Sacred Heart

Recruiting

Pensacola, Florida, United States, 32504

Ascension St. Vincent

Recruiting

Indianapolis, Indiana, United States, 46290

Ascension Via Christi Saint Francis

Recruiting

Wichita, Kansas, United States, 67214

Ascension Saint Agnes Heart Care

Recruiting

Baltimore, Maryland, United States, 21229

Corewell Health William Beaumont University Hospital

Recruiting

Royal Oak, Michigan, United States, 48073

St. Francis Hospital

Recruiting

Roslyn, New York, United States, 11576

Mission Hospital

Recruiting

Asheville, North Carolina, United States, 28801

The Lindner Center for Research at Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

WellSpan Health

Recruiting

York, Pennsylvania, United States, 17403

TriStar Centennial Medical Center

Recruiting

Nashville, Tennessee, United States, 37203

Ascension St. Thomas Hospital

Recruiting

Nashville, Tennessee, United States, 37236

Ascension Seton Hays

Recruiting

Kyle, Texas, United States, 78640

Ascension Columbia St. Mary's Hospital

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

Orchestra BioMed, Inc

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • In-Stent Restenosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Orchestra BioMed, Inc on 2026-07-23.