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Study identifier: NCT04634240 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement

Condition: Aortic Stenosis · Coronary Artery Disease · Coronary Stenosis  ·  Sponsor: University of British Columbia

PhaseNA
Planned participants4000
Who can joinAll sexes, N/A to no upper limit
Healthy volunteersNo

About this study

Patients undergoing transcatheter aortic valve replacement (TAVR) often have concomitant coronary artery disease (CAD) which may adversely affect prognosis. There is uncertainty about the benefits and the optimal timing of revascularization for such patients. There is currently clinical equipoise regarding the management of concomitant CAD in patients undergoing TAVR. Some centers perform routine revascularization with percutaneous coronary intervention (PCI) (either before or after TAVR), while others follow an alternative strategy of medical management. The potential benefits and optimal timing of PCI in these patients are unknown. As TAVR expands to lower risk patients, and potentially becomes the preferred therapy for the majority of patients with severe aortic stenosis, the optimal management of concomitant coronary artery disease will be of increasing importance. The COMPLETE TAVR study will determine whether, on a background of guideline-directed medical therapy, a strategy of complete revascularization involving staged PCI using drug eluting stents to treat all suitable coronary artery lesions is superior to a strategy of medical therapy alone in reducing the composite outcome of Cardiovascular Death, new Myocardial Infarction, Ischemia-driven Revascularization or Hospitalization for Unstable Angina or Heart Failure. The study will be a randomized, multicenter, open-label trial with blinded adjudication of outcomes. Patients will be screened and consented for elect…

This description comes directly from the study's public registry record.

Talk to the study team

Brady J Robinson, CCRP  ·  604-875-4111  ·  brobinson@cci-cic.org

Always discuss trial participation with your own doctor first.

Locations (72)

Huntsville Heart CenterHuntsville, Alabama, United StatesRecruiting
Arizona Cardiovascular ResearchPhoenix, Arizona, United StatesRecruiting
Veteran Affairs Palo Alto Health Care SystemPalo Alto, California, United StatesRecruiting
Loma Linda UniversityRedlands, California, United StatesRecruiting
Santa Barbara Cottage HospitalSanta Barbara, California, United StatesRecruiting
Torrance Memorial Medical CenterTorrance, California, United StatesRecruiting
JFK Medical CenterAtlantis, Florida, United StatesRecruiting
Baptist Health JacksonvilleJacksonville, Florida, United StatesRecruiting
Miami Cardiac and Vascular/Baptist HospitalMiami, Florida, United StatesRecruiting
PiedmontAtlanta, Georgia, United StatesRecruiting
Northeast Georgia Health SystemGainesville, Georgia, United StatesRecruiting
St. Alphonsus Regional Medical CenterBoise, Idaho, United StatesRecruiting

+ 60 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT04634240