RECRUITING Phase 3 ClinicalTrials.gov

REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial - Women

Sponsor: Weill Medical College of Cornell University • ClinicalTrials.gov ID: NCT06399692

Registry updated: 2026-09-08

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Description

This is a research study in women 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.

Interventions

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

Eligibility criteria

Inclusion Criteria: 1. Female sex 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 in-stent restenosis with diameter stenosis ≥50% or any prior cardiac surgery 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, with the exception that surgical or interventional left atrial appendage ligation or occlusion and/or atrial fibrillation ablation may be performed at site discretion either during or subsequent to the index revascularization procedure 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 8. 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 9. Current participation in another investigational drug or device study that has not reached its primary endpoint 10. Life-expectancy less than 3 years due to concomitant non-cardiac conditions 11. 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.)

Conditions

Coronary Artery Disease

Locations

Adventist Health Glendale — Glendale, California, United States
Emory University — Atlanta, Georgia, United States
Ascension St. Vincent Cardiovascular Research Institute — Carmel, Indiana, United States
Baptist Health Lexington — Lexington, Kentucky, United States
Baptist Health Louisville — Louisville, Kentucky, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Englewood Hospital — Englewood, New Jersey, United States
NewYork-Presbyterian Hospital - Queens — Flushing, New York, United States
Icahn School of Medicine - Mount Sinai Morningside — New York, New York, United States
Icahn School of Medicine - Mount Sinai Hospital — New York, New York, United States
Columbia University Irving Medical Center/NewYork-Presbyterian Hospital — New York, New York, United States
Weill Cornell Medicine / NYPH — New York, New York, United States
Westchester Medical Center — Valhalla, New York, United States
Duke University — Durham, North Carolina, United States
Ohio State University — Columbus, Ohio, United States
Methodist Le Bonheur Healthcare — Memphis, Tennessee, United States
Ascension Saint Thomas Hospital — Nashville, Tennessee, United States
Baylor Scott and White — Dallas, Texas, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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