New balloon could offer alternative for clogged heart stents

NCT ID NCT07045194

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

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.

Get updates

Get notified about this study

Our safety recommendation!

By submitting, you agree to our Terms of use

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

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.