Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New balloon could offer alternative for clogged heart stents

NCT ID NCT07045194

Disease control Sponsor: Orchestra BioMed, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 24, 2026 · Updated 3 times

Summary

This study tests a new balloon coated with sirolimus (Virtue SAB) against an existing balloon coated with paclitaxel (AGENT DCB) for treating in-stent restenosis — when a previously placed stent in a heart artery becomes blocked again. About 740 people with one re-narrowed stent will be randomly assigned to receive one of the two balloons during a procedure. The main goal is to see if the sirolimus balloon works as well as the paclitaxel balloon at preventing heart-related problems one year later.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sirolimus (on a balloon catheter)
What this could lead to
If it works, this could offer an alternative treatment for re-narrowed heart arteries, potentially reducing the need for repeat procedures.
What could go wrong
This is a non-inferiority trial, meaning it aims to show the new balloon is not worse than the existing one, not that it is better. The study is still recruiting, and results are not yet available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 740 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Oct 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Coronary artery disease are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

coronary artery disorder coronary restenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary artery disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ascension Columbia St. Mary's Hospital

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Ascension Sacred Heart

    RECRUITING

    Pensacola, Florida, 32504, United States

  • Ascension Saint Agnes Heart Care

    RECRUITING

    Baltimore, Maryland, 21229, United States

  • Ascension Seton Hays

    RECRUITING

    Kyle, Texas, 78640, United States

  • Ascension St. Thomas Hospital

    RECRUITING

    Nashville, Tennessee, 37236, United States

  • Ascension St. Vincent

    RECRUITING

    Indianapolis, Indiana, 46290, United States

  • Ascension Via Christi Saint Francis

    RECRUITING

    Wichita, Kansas, 67214, United States

  • Corewell Health William Beaumont University Hospital

    RECRUITING

    Royal Oak, Michigan, 48073, United States

  • Mission Hospital

    RECRUITING

    Asheville, North Carolina, 28801, United States

  • St. Francis Hospital

    RECRUITING

    Roslyn, New York, 11576, United States

  • The Cardiac and Vascular Institute

    RECRUITING

    Gainesville, Florida, 32605, United States

  • The Lindner Center for Research at Christ Hospital

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • Thomas Jefferson University

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • TriStar Centennial Medical Center

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • WellSpan Health

    RECRUITING

    York, Pennsylvania, 17403, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.