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Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement
Sponsor: University of British Columbia
Summary
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 elective transfemoral TAVR and randomized within 96 hours of successful balloon expandable TAVR. Complete Revascularization: Staged PCI using third generation drug eluting stents to treat all suitable coronary artery lesions in vessels that are at least 2.5 mm in diameter and that are amenable to treatment with PCI and have a ≥70% visual angiographic diameter stenosis. Staged PCI can occur any time from 1 to 45 days post successful transfemoral TAVR. Vs. Medical Therapy Alone: No further revascularization of coronary artery lesions. All patients, regardless of randomized treatment allocation, will receive guideline-directed medical therapy consisting of risk factor modification and use of evidence-based therapies. The COMPLETE TAVR study will help address the current lack of evidence in this area. It will likely impact both the global delivery of health care and the management and clinical outcomes of all patients undergoing TAVR with concomitant CAD.
Official title: A Randomized, Comparative Effectiveness Study of Staged Complete Revascularization With Percutaneous Coronary Intervention to Treat Coronary Artery Disease vs Medical Management Alone in Patients With Symptomatic Aortic Valve Stenosis Undergoing Elective Transfemoral Transcatheter Aortic Valve Replacement: The COMPLETE TAVR Study
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
4000
Start Date
2020-12-19
Completion Date
2026-04-01
Last Updated
2025-07-24
Healthy Volunteers
No
Interventions
Percutaneous Coronary Intervention (PCI)
PCI of all qualifying lesions.
Locations (72)
Huntsville Heart Center
Huntsville, Alabama, United States
Arizona Cardiovascular Research
Phoenix, Arizona, United States
Veteran Affairs Palo Alto Health Care System
Palo Alto, California, United States
Loma Linda University
Redlands, California, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, United States
Torrance Memorial Medical Center
Torrance, California, United States
JFK Medical Center
Atlantis, Florida, United States
Baptist Health Jacksonville
Jacksonville, Florida, United States
Miami Cardiac and Vascular/Baptist Hospital
Miami, Florida, United States
Piedmont
Atlanta, Georgia, United States
Northeast Georgia Health System
Gainesville, Georgia, United States
St. Alphonsus Regional Medical Center
Boise, Idaho, United States
Ascension Alexian Brothers
Chicago, Illinois, United States
Midwest Cardiovascular Research and Education Foundation
Elkhart, Indiana, United States
Parkview Research Center
Fort Wayne, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Midwest Heart and Vascular
Overland Park, Kansas, United States
Cardiovascular Research Institute of Kansas
Wichita, Kansas, United States
Tufts Medical
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Sparrow Clinical Research Institute
Lansing, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Ascension St. Mary's
Saginaw, Michigan, United States
St. Joseph Mercy Health System
Ypsilanti, Michigan, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota, United States
Boone Hospital
Columbia, Missouri, United States
St. Louis University
St Louis, Missouri, United States
Missouri Baptist
St Louis, Missouri, United States
Bryan Heart
Lincoln, Nebraska, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Our Lady of Lourdes
Camden, New Jersey, United States
Valley Hospital
Ridgewood, New Jersey, United States
University at Buffalo
Buffalo, New York, United States
NYU Langone Hospital - Long Island
Mineola, New York, United States
Mount Sinai
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
St. Joseph's Hospital
Syracuse, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Novant Health Heart and Vascular Institute
Charlotte, North Carolina, United States
Summa Health System
Akron, Ohio, United States
Mount Carmel
Columbus, Ohio, United States
Oklahoma Heart
Oklahoma City, Oklahoma, United States
Kaiser Permanente Northwest
Clackamas, Oregon, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Methodist Le Bonheur Healthcare
Germantown, Tennessee, United States
Ballad Health CVA Heart Institute
Kingsport, Tennessee, United States
Parkwest Medical Center
Knoxville, Tennessee, United States
Cardiovascular Surgery Clinic/Baptist Memorial
Memphis, Tennessee, United States
HCA Houston Healthcare Medical Center
Houston, Texas, United States
Baylor Scott & White Plano
Plano, Texas, United States
Baylor Scott & White Round Rock
Round Rock, Texas, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Bellin Health System
Green Bay, Wisconsin, United States
Ascension Columbia St. Mary's
Milwaukee, Wisconsin, United States
University of Alberta, Mazankowski Heart Institute
Edmonton, Alberta, Canada
Royal Columbian Hospital
New Westminster, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Centre for Cardiovascular Innovation-Centre d'Innovation Cardiovasculaire (CCI-CIC)
Vancouver, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Saint Boniface
Winnipeg, Manitoba, Canada
New Brunswick Heart
Saint John, New Brunswick, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
Ottawa Heart
Ottawa, Ontario, Canada
Sunnybrook Hospital
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Montréal Heart
Montreal, Quebec, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Sacré-Coeur
Montreal, Quebec, Canada
CIUSSS de l'Estrie-CHUS
Sherbrooke, Quebec, Canada
Prairie Vascular
Regina, Saskatchewan, Canada