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RecruitingNCT07045194Updated Oct 22, 2026

Virtue® SAB in the Treatment of Coronary ISR Trial

An interventional study of Virtue Sirolimus AngioInfusion Balloon and AGENT™ Paclitaxel Drug-Coated Balloon in Coronary Artery Disease, sponsored by Orchestra BioMed, Inc. Recruiting at 22 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Orchestra BioMed, Inc · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.
Updated Oct 22, 20267 sites addedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
740
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

Read the detailed description

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).

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • In-Stent Restenosis
03

In context

Coronary Artery Disease

4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.

This study's planned enrollment of 740 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Orchestra BioMed, Inc is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Subject has a \< 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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
740 participants (estimated)

Study arms

  • Experimental
    Virtue SAB

    Coronary PCI, Sirolimus AngioInfusion Balloon (SAB)

    Device: Virtue Sirolimus AngioInfusion Balloon

  • Active comparator
    AGENT™ DCB

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

    Device: AGENT™ Paclitaxel Drug-Coated Balloon

Interventions

  • DeviceVirtue Sirolimus AngioInfusion Balloon

    Percutaneous Coronary Intervention

  • DeviceAGENT™ Paclitaxel Drug-Coated Balloon

    Percutaneous Coronary Intervention

06

What researchers measure

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)

    Time frame: 12 months

Secondary outcomes

  1. 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

07

Study locations

22 of 22 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2025 (actual). Primary completion is estimated for Oct 2028, 36 months after the start.

Of 177 industry-sponsored interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 40. This study's planned 36 months is above that.

Counting every sponsor, half of 930 studies reached it within 30 months; a quarter within 15 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 16, 2025
First posted
Jul 1, 2025
StartActual
Oct 20, 2025
Primary completionEst.
Oct 2028
CompletionEst.
Oct 2032
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
7 sites added
Show 7 added (7 United States)
  • Banner University Medical Center Phoenix · Phoenix, United States
  • Memorial Regional Hospital · Hollywood, United States
  • Emory University Hospital · Atlanta, United States
  • Baystate Health · Springfield, United States
  • Cardiology Associates of North Misssissippi · Tupelo, United States
  • Icahn School of Medicine at Mount Sinai · New York, United States
  • PRISMA Health · Greenville, United States
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    7 sites added
    Show 7 added (7 United States)
    • Banner University Medical Center Phoenix · Phoenix, United States
    • Memorial Regional Hospital · Hollywood, United States
    • Emory University Hospital · Atlanta, United States
    • Baystate Health · Springfield, United States
    • Cardiology Associates of North Misssissippi · Tupelo, United States
    • Icahn School of Medicine at Mount Sinai · New York, United States
    • PRISMA Health · Greenville, United States
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07045194
Lead sponsor
Orchestra BioMed, Inc
Responsible party
Sponsor
First posted
Jul 1, 2025
Start date
Oct 20, 2025
Primary completion
Oct 2028 (estimated)
Completion
Oct 2032 (estimated)
Last update
Oct 22, 2026

Study contacts

Hans-Peter Stoll, MD, PHD
Contact
hpstoll@orchestrabiomed.com
646-956-2161
Amy Berman, MPH
Contact
aberman@orchestrabiomed.com
Dean Kereiakes, MD
principal investigator · Lindner Center for Research at Christ Hospital
Allen Jeremias, MD
principal investigator · St. Francis Hospital & Heart Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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