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

Status: Recruiting
Location: See all (18) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Female sex

• Patient is at least 18 years old.

• 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.

• Ability to provide written informed consent and comply with all follow-up procedures, including QOL questionnaires.

Locations
United States
California
Adventist Health Glendale
RECRUITING
Glendale
Georgia
Emory University
RECRUITING
Atlanta
Indiana
Ascension St. Vincent Cardiovascular Research Institute
RECRUITING
Carmel
Kentucky
Baptist Health Lexington
RECRUITING
Lexington
Baptist Health Louisville
RECRUITING
Louisville
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
North Carolina
Duke University
RECRUITING
Durham
New Jersey
Englewood Hospital
RECRUITING
Englewood
New York
NewYork-Presbyterian Hospital - Queens
RECRUITING
Flushing
Columbia University Irving Medical Center/NewYork-Presbyterian Hospital
RECRUITING
New York
Icahn School of Medicine - Mount Sinai Hospital
RECRUITING
New York
Icahn School of Medicine - Mount Sinai Morningside
RECRUITING
New York
Weill Cornell Medicine / NYPH
RECRUITING
New York
Westchester Medical Center
RECRUITING
Valhalla
Ohio
Ohio State University
RECRUITING
Columbus
Tennessee
Methodist Le Bonheur Healthcare
RECRUITING
Memphis
Ascension Saint Thomas Hospital
RECRUITING
Nashville
Texas
Baylor Scott and White
RECRUITING
Dallas
Contact Information
Primary
Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC
mfg9004@med.cornell.edu
212.746.1812
Backup
Gregg Stone, MD, FACC, MSCAI
Gregg.Stone@mountsinai.org
Time Frame
Start Date: 2024-09-16
Estimated Completion Date: 2039-01-01
Participants
Target number of participants: 600
Treatments
Other: RECHARGE:Women - CABG
Other: RECHARGE:Women - PCI
Sponsors
Collaborators: Icahn School of Medicine at Mount Sinai, Patient-Centered Outcomes Research Institute
Leads: Weill Medical College of Cornell University

This content was sourced from clinicaltrials.gov