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

RecruitingPhase 3

Sponsor: Weill Medical College of Cornell University

Conditions: Coronary Artery Disease

Interventions: Coronary artery bypass grafting (CABG), Percutaneous coronary intervention (PCI)

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.)

Locations (18)

Glendale, California, United States
Atlanta, Georgia, United States
Carmel, Indiana, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Boston, Massachusetts, United States
Englewood, New Jersey, United States
Flushing, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Valhalla, New York, United States
Durham, North Carolina, United States
Columbus, Ohio, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States