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NCT07045194ClinicalTrials.gov

Virtue® SAB in the Treatment of Coronary ISR Trial

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).

RecruitingTaking participants now, according to the registry record.
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In brief

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).

Interventional740 participants sought15 sites1 country

Categories

Cardiovascular100%

Registered in 1 registry

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Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2025-07-01; recorded start 2025-10-20
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 1 other study in this databaseCounted from the lead sponsor named in the record (Orchestra BioMed, Inc)
  • No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding7/20

    Single-blind

  • Control arm15/15

    Active-comparator control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 15 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study: 740 participants (target), run at 15 sites.

How this score is built
  • Enrolment28/40

    740 participants (target)

  • Site count14/25

    15 sites

  • Country count0/15

    Single country

  • Planned duration10/10

    Planned over about 85 months

  • Sponsor scale1/10

    Orchestra BioMed, Inc has led 2 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

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).

The Virtue® ISR trial is a prospective, multi-center, single-blind, randomized (1:1), non-inferiority study. The Virtue® Sirolimus AngioInfusion™ Balloon (SAB) will be compared to the AGENT Paclitaxel Drug-Coated Balloon (DCB) in the treatment of coronary artery in-stent restenosis (ISR).

Conditions

  • Coronary Artery Disease

Eligibility

SexAll
Ages18 Years – No maximum
Healthy volunteersNo

Eligibility as written in the registry

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.

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study typeInterventional
PhaseNot applicable
AllocationRandomised
Intervention modelPARALLEL
Primary purposeTREATMENT
MaskingSINGLE (1)
Enrolment740 participants sought

Sponsor and collaborators

  • Orchestra BioMed, Inc Sponsor

Arms and interventions

  • Virtue SABEXPERIMENTAL

    Coronary PCI, Sirolimus AngioInfusion Balloon (SAB)

  • AGENT™ DCBACTIVE_COMPARATOR

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

Interventions

  • Device AGENT™ Paclitaxel Drug-Coated Balloon

    Percutaneous Coronary Intervention

  • Device Virtue Sirolimus AngioInfusion Balloon

    Percutaneous Coronary Intervention

Outcome measures

  1. Primary outcome

    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)

    Time frame 12 months

  2. Secondary outcome

    Target Lesion Failure (TLF) Comparison at 12 months

    Target Lesion Failure (TLF) at 12 months of subjects treated with Virtue® SAB compared to a PBA Performance Goal.

    Time frame 12 months

Dates

Start dateOctober 20, 2025 (actual)
Primary completionOctober 1, 2028 (estimated)
CompletionOctober 1, 2032 (estimated)
First postedJuly 1, 2025 (actual)
Last updatedJuly 23, 2026
Results postedNot stated in the registry record
Status last verifiedJuly 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

15 sites are recruiting

United States

FacilityCityState or regionStatus
Mission HospitalAshevilleNorth CarolinaRecruiting
Ascension Saint Agnes Heart CareBaltimoreMarylandRecruiting
The Lindner Center for Research at Christ HospitalCincinnatiOhioRecruiting
The Cardiac and Vascular InstituteGainesvilleFloridaRecruiting
Ascension St. VincentIndianapolisIndianaRecruiting
Ascension Seton HaysKyleTexasRecruiting
Ascension Columbia St. Mary's HospitalMilwaukeeWisconsinRecruiting
TriStar Centennial Medical CenterNashvilleTennesseeRecruiting
Ascension St. Thomas HospitalNashvilleTennesseeRecruiting
Ascension Sacred HeartPensacolaFloridaRecruiting
Thomas Jefferson UniversityPhiladelphiaPennsylvaniaRecruiting
St. Francis HospitalRoslynNew YorkRecruiting
Corewell Health William Beaumont University HospitalRoyal OakMichiganRecruiting
Ascension Via Christi Saint FrancisWichitaKansasRecruiting
WellSpan HealthYorkPennsylvaniaRecruiting

Study documents

No documents are linked in this registry record.

Changes over time

No changes have been recorded since we first ingested this record.

A change is recorded each time the sponsor updates the registry record. Status, dates, enrolment and sites appear here as they move.

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07045194