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RECRUITINGPhase 3INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form and comply with all follow-up procedures, including QOL questionnaires. Who Should NOT Join This Trial: 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 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.) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 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 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.)

Treatments Being Tested

PROCEDURE

Coronary artery bypass grafting (CABG)

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

PROCEDURE

Percutaneous coronary intervention (PCI)

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

Locations (18)

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