Virtue® SAB in the Treatment of Coronary ISR Trial

NCT07045194 | Recruiting DMC FDA Device

• 1 other identifier: Protocol - 0072
• Study Type: interventional
• Target: 740
• Locations: 1 country
• Sites: 15

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

Keywords

In-Stent Restenosis

Outcome Measures

Primary Outcomes (1)

• Target Lesion Failure (TLF) at 12 months

  Defined as a composite of cardiac death (CD), non-fatal target vessel myocardial infarction (MI) SCAI definition, and ischema-driven target lesion revascularization (TLR)

  12 months

Secondary Outcomes (1)

• Target Lesion Failure (TLF) Comparison at 12 months

  12 months

Study Arms (2)

Virtue SAB

EXPERIMENTAL

Coronary PCI, Sirolimus AngioInfusion Balloon (SAB)

Device: Virtue Sirolimus AngioInfusion Balloon

AGENT™ DCB

ACTIVE COMPARATOR

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

Device: AGENT™ Paclitaxel Drug-Coated Balloon

Interventions

AGENT™ Paclitaxel Drug-Coated Balloon DEVICE

Percutaneous Coronary Intervention

AGENT™ DCB

Virtue Sirolimus AngioInfusion Balloon DEVICE

Percutaneous Coronary Intervention

Virtue SAB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Orchestra BioMed, Inc: lead

Study Sites (15)

The Cardiac and Vascular Institute

Gainesville, Florida, 32605, United States

RECRUITING

Ascension Sacred Heart

Pensacola, Florida, 32504, United States

RECRUITING

Ascension St. Vincent

Indianapolis, Indiana, 46290, United States

RECRUITING

Ascension Via Christi Saint Francis

Wichita, Kansas, 67214, United States

RECRUITING

Ascension Saint Agnes Heart Care

Baltimore, Maryland, 21229, United States

RECRUITING

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073, United States

RECRUITING

St. Francis Hospital

Roslyn, New York, 11576, United States

RECRUITING

Mission Hospital

Asheville, North Carolina, 28801, United States

RECRUITING

The Lindner Center for Research at Christ Hospital

Cincinnati, Ohio, 45219, United States

RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

WellSpan Health

York, Pennsylvania, 17403, United States

RECRUITING

TriStar Centennial Medical Center

Nashville, Tennessee, 37203, United States

RECRUITING

Ascension St. Thomas Hospital

Nashville, Tennessee, 37236, United States

RECRUITING

Ascension Seton Hays

Kyle, Texas, 78640, United States

RECRUITING

Ascension Columbia St. Mary's Hospital

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Dean Kereiakes, MD

  Lindner Center for Research at Christ Hospital

  PRINCIPAL INVESTIGATOR

• Allen Jeremias, MD

  St. Francis Hospital & Heart Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hans-Peter Stoll, MD, PHD

CONTACT

646-956-2161; hpstoll@orchestrabiomed.com

Amy Berman, MPH

CONTACT

aberman@orchestrabiomed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: July 1, 2025
• Study Start: October 20, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2032
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)