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Comparing heart procedures for women with coronary artery disease

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

Phase 3 Interventional Weill Medical College of Cornell University · NCT06399692

This study is testing which heart procedure, ballooning and stenting or open-heart surgery, works better for women with coronary artery disease to improve their health and quality of life.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment600 (estimated)
Ages18 Years and up
SexAll
SponsorWeill Medical College of Cornell University Academic / other
Locations18 sites (Glendale, California and 17 other locations)
Trial IDNCT06399692 on ClinicalTrials.gov

What this trial studies

This trial evaluates two procedures for restoring blood flow in women with coronary artery disease: percutaneous coronary intervention (PCI), which involves ballooning and stenting blockages, and coronary artery bypass grafting (CABG), an open-heart surgery that uses healthy blood vessels to bypass blockages. It is a multicenter, randomized trial where participants will be followed for 5-10 years to assess survival rates and quality of life improvements. The study aims to provide insights into the best revascularization options for women, a group often underrepresented in cardiovascular research.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 and older with multivessel or left main coronary artery disease who are eligible for either CABG or PCI.

Not a fit: Patients with recent heart attacks, severe heart conditions, or those requiring other cardiac procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options and outcomes for women with coronary artery disease.

How similar studies have performed: Other studies have shown success in comparing these revascularization techniques, but this trial specifically focuses on women, making it a novel approach.

Eligibility criteria

Show full inclusion / exclusion 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 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.)

Where this trial is running

Glendale, California and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Coronary Artery DiseaseRECHARGECardiac Surgerycoronary artery bypass graftingpercutaneous coronary interventionQuality of Life
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.