Recruiting
Phase 3

Ballooning & Bypass

Sponsor:

Weill Medical College of Cornell University

Code:

NCT06399705

Conditions

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Coronary artery bypass grafting

Percutaneous coronary intervention

Study Details

Brief summary:

This is a research study in minorities to compare the outcomes of two procedures that restore blood flow to the arteries of the heart. In one procedure the blockages are ballooned and then stented with a small wire mesh tube through a small incision in the wrist or the groin. The other procedure is an open-heart operation in which healthy blood vessels from inside the chest, leg, and/or forearm are used to "bypass" the blockages (like a detour). Outcomes will be measured by comparing survival and improvement in quality-of-life.

Conditions

Coronary Artery Disease

Study ID

NCT06399705

Start date

Oct 2, 2024

Status verified date

Sep, 2025

Completion date

Jan 1, 2039

Anticipated

Primary completion date

Mar 15, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patient must identify as a minority
2. Patient is at least 18 years old.
3. Multivessel or left main CAD is present for which revascularization is intended and for which there is equipoise between CABG and PCI according to local Heart Team assessment.
4. Ability to provide written informed consent and comply with all follow-up procedures, including QOL questionnaires.

Exclusion Criteria:

1. ST-segment elevation MI within 3 days
2. Cardiogenic shock
3. Prior PCI within 1 year or any prior CABG anytime
4. Planned hybrid revascularization (PCI after CABG or CABG after PCI)
5. Planned single vessel revascularization (other than isolated left main disease)
6. Need for any cardiac surgical or interventional procedure other than coronary revascularization at the present time or anticipated within 3 years
7. Pregnancy (women of child-bearing potential must have a negative pregnancy test within 1 week before randomization) or intent to become pregnant within 1 year after randomization Unable to tolerate, obtain or comply with dual antiplatelet therapy for at least 3 months if presentation with stable CAD or 6 months if presentation with a troponin-positive acute coronary syndrome Current participation in another investigational drug or device study that has not reached its primary endpoint Life-expectancy less than 3 years due to concomitant non-cardiac conditions Any condition(s) are present that are likely to interfere with the study protocol procedures including medication adherence and follow-up through 10 years (e.g. mental disability, substance abuse, anticipated international relocation, etc.)

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: RECHARGE: Minorities - CABG

other: RECHARGE: Minorities - PCI

Interventions

Coronary artery bypass grafting

Coronary artery bypass grafting (CABG), also called heart bypass surgery, is a medical procedure to improve blood flow to the heart.

Percutaneous coronary intervention

Percutaneous coronary intervention (PCI) is a non-surgical procedure used to treat the blockages in a coronary artery; it opens up narrowed or blocked sections of the artery, restoring blood flow to the heart

Primary outcome measure

  • Hierarchical composite of all-cause death and time-averaged change from baseline in generic quality of life using the SF-12v2 [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC

Gregg.Stone@mountsinai.orgmfg9004@med.cornell.edu

Gregg Stone, MD, FACC, MSCAI

Gregg.Stone@mountsinai.org

Locations

Adventist Health Glendale

Recruiting

Glendale, California, United States, 91206

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Ascension St. Vincent Cardiovascular Research Institute

Recruiting

Carmel, Indiana, United States, 46290

Baptist Health Lexington

Recruiting

Lexington, Kentucky, United States, 40503

Baptist Health Louisville

Recruiting

Louisville, Kentucky, United States, 40207

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Englewood Hospital

Recruiting

Englewood, New Jersey, United States, 07631

NewYork-Presbyterian Hospital - Queens

Recruiting

Flushing, New York, United States, 11355

Icahn School of Medicine - Mount Sinai Morningside

Recruiting

New York, New York, United States, 10025

Icahn School of Medicine - Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Columbia University Irving Medical Center/NewYork-Presbyterian Hospital

Recruiting

New York, New York, United States, 10032

Weill Cornell Medicine/NewYork-Presbyterian Hospital

Recruiting

New York, New York, United States, 10065

Westchester Medical Center

Recruiting

Valhalla, New York, United States, 10595

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Methodist Le Bonheur Healthcare

Recruiting

Memphis, Tennessee, United States, 38104

Ascension Saint Thomas Hospital

Recruiting

Nashville, Tennessee, United States, 37205

Baylor Scott and White

Recruiting

Dallas, Texas, United States, 75246

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Oct 1, 2025

Last verified

Sep, 2025

Keywords

  • RECHARGE
  • Cardiac Surgery
  • Minority
  • percutaneous coronary intervention
  • Quality of Life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2025-10-01.