Coronary Artery DiseaseNCT07045194
Virtue® SAB in the Treatment of Coronary ISR Trial
A study testing Virtue Sirolimus AngioInfusion Balloon and AGENT™ Paclitaxel Drug-Coated Balloon in people with Coronary Artery Disease, run by Orchestra BioMed, Inc at 22 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Virtue Sirolimus AngioInfusion Balloon and AGENT™ Paclitaxel Drug-Coated Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 740 participants
- Where
- 22 sitesUnited States
- Study dates
- 20 Oct 2025to Oct 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Amy Berman, MPH contact
22 sites in 1 country
United States22 sites, 22 recruiting
- Recruiting
Mission Hospital
Asheville, North Carolina, 28801
Grace Raegan
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322,
Wei Xu
- Recruiting
Ascension Saint Agnes Heart Care
Baltimore, Maryland, 21229
Heather T Blubaugh
- Recruiting
The Lindner Center for Research at Christ Hospital
Cincinnati, Ohio, 45219
T Buchtmann
- Recruiting
The Cardiac and Vascular Institute
Gainesville, Florida, 32605
Carissa Fertil
- Recruiting
PRISMA Health
Greenville, South Carolina, 29601
Kenneth Alfieri
- Recruiting
Memorial Regional Hospital
Hollywood, Florida, 33312
Catherine Castro
- Recruiting
Ascension St. Vincent
Indianapolis, Indiana, 46290
Jessica Green
- Recruiting
Ascension Seton Hays
Kyle, Texas, 78640
Abigail Alvarado
- Recruiting
Ascension Columbia St. Mary's Hospital
Milwaukee, Wisconsin, 53226
Stephenee Supan
- Recruiting
TriStar Centennial Medical Center
Nashville, Tennessee, 37203
Amara Howard
- Recruiting
Ascension St. Thomas Hospital
Nashville, Tennessee, 37236
Peiman Nebi
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Nimisha Baruah
- Recruiting
Ascension Sacred Heart
Pensacola, Florida, 32504
Jessica Flores
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Elizabeth Robinson
- Recruiting
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
Erin Downey
- Recruiting
St. Francis Hospital
Roslyn, New York, 11576
E Haag
- Recruiting
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073
Rachel Wylie
- Recruiting
Baystate Health
Springfield, Massachusetts, 01199
Keoni Bermoy
- Recruiting
Cardiology Associates of North Misssissippi
Tupelo, Mississippi, 38801
Amber Jerrigan
- Recruiting
Ascension Via Christi Saint Francis
Wichita, Kansas, 67214
Kristen Thomas
- Recruiting
WellSpan Health
York, Pennsylvania, 17403
Lori Slenker
About this study
Official title: 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).
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).
- Conditions
- Coronary Artery Disease
- Being tested
- Virtue Sirolimus AngioInfusion Balloon, AGENT™ Paclitaxel Drug-Coated Balloon
- Keywords
- In-Stent Restenosis
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtue Sirolimus AngioInfusion BalloonDevice
Percutaneous Coronary Intervention
AGENT™ Paclitaxel Drug-Coated BalloonDevice
Percutaneous Coronary Intervention
| Study group | Role | What they receive |
|---|---|---|
| Virtue SAB | Experimental | Coronary PCI, Sirolimus AngioInfusion Balloon (SAB) Receives: Device: Virtue Sirolimus AngioInfusion Balloon |
| AGENT™ DCB | Active comparator | Coronary Angioplasty, AGENT™ Paclitaxel Drug-Coated Balloon (DCB) Receives: Device: AGENT™ Paclitaxel Drug-Coated Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start20 Oct 2025
- Primary completionOct 2028 (estimated)
- Study completionOct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 740 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orchestra BioMed, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dean Kereiakes, MD, Principal investigator, Lindner Center for Research at Christ HospitalAllen Jeremias, MD, Principal investigator, St. Francis Hospital & Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045194
- Sponsor's protocol ID
- Protocol - 0072
- Status last verified
- Oct 2026
- First submitted
- 16 Jun 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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).
- ClinicalTrials.gov ID
- NCT07045194
- Acronym / sponsor ID
- Protocol - 0072
- Conditions
- Coronary Artery Disease
- Keywords
- In-Stent Restenosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 740 participants (estimated)
- Lead sponsor
- Orchestra BioMed, IncIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2032 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtue SAB | Experimental | Device: Virtue Sirolimus AngioInfusion BalloonCoronary PCI, Sirolimus AngioInfusion Balloon (SAB) |
| AGENT™ DCB | Active comparator | Device: AGENT™ Paclitaxel Drug-Coated BalloonCoronary Angioplasty, AGENT™ Paclitaxel Drug-Coated Balloon (DCB) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtue Sirolimus AngioInfusion BalloonPercutaneous Coronary Intervention | Device | Virtue SAB |
| AGENT™ Paclitaxel Drug-Coated BalloonPercutaneous Coronary Intervention | Device | AGENT™ DCB |
Primary outcome
Target Lesion Failure (TLF) at 12 months
Time frame: 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)
1 secondary outcome
Target Lesion Failure (TLF) Comparison at 12 months
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy Berman, MPH contact
Dean Kereiakes, MD principal investigator
Lindner Center for Research at Christ Hospital
Allen Jeremias, MD principal investigator
St. Francis Hospital & Heart Center
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtue Sirolimus AngioInfusion Balloon and AGENT™ Paclitaxel Drug-Coated Balloon in people with Coronary Artery Disease, run by Orchestra BioMed, Inc at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hans-Peter Stoll, MD, PHD (646-956-2161, hpstoll@orchestrabiomed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Failure (TLF) at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.