Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement
NCT ID: NCT04634240
Last Updated: 2025-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
4000 participants
INTERVENTIONAL
2020-12-19
2026-04-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Complete Revascularization
Routine PCI (percutaneous coronary intervention) of all suitable coronary artery stenoses of ≥70% in vessels ≥2.5mm in diameter.
Percutaneous Coronary Intervention (PCI)
PCI of all qualifying lesions.
Medical Therapy Alone
No revascularization of coronary artery lesions.
No interventions assigned to this group
Interventions
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Percutaneous Coronary Intervention (PCI)
PCI of all qualifying lesions.
Eligibility Criteria
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Inclusion Criteria
AND
\- CAD defined as: at least 1 coronary artery lesion of ≥70% visual angiographic diameter stenosis in a native segment ≥2.5 mm in diameter that is not a CTO and is amenable to treatment with PCI
AND
\- Consensus by the Local Multidisciplinary Heart Team that the patient is suitable for elective transfemoral TAVR with a balloon expandable transcatheter heart valve AND would receive a bypass with an anastomosis distal to the coronary artery lesion(s) if they were undergoing SAVR.
Local Multidisciplinary Heart Teams are expected to follow current clinical guidelines for selection of patients for TAVR with an eligible patient generally expected to have:
\[AVA ≤ 1.0 cm2 OR AVA index ≤ 0.6 cm2/m2\]
OR
\[Jet velocity ≥ 4.0 m/s OR mean gradient ≥ 40 mmHg\]
OR
patients without these criteria may undergo TAVR if the Local Multidisciplinary Heart Team concludes it is appropriate.
AND
\- Successful transfemoral TAVR, defined as the implantation of a single transcatheter aortic valve within the past 96 hours with freedom from more than minimal aortic insufficiency, stroke, or major vascular complications.
Exclusion Criteria
* Planned PCI of coronary artery lesion(s)
* Planned surgical revascularization of coronary artery lesion(s)
* Non-cardiovascular co-morbidity reducing life expectancy to \< 5 years
* Any factor precluding 5-year follow-up
* Prior coronary artery bypass grafting surgery or surgical valve replacement
* Severe mitral regurgitation (\> 3+)
* Severe left ventricular dysfunction (LVEF \< 30%)
* Low coronary takeoff (high risk for coronary obstruction)
* Acute myocardial infarction within 90 days
* Stroke or transient ischemic attack within 90 days
* Renal insufficiency (eGFR \< 30 ml/min) and/or renal replacement Rx
* Hemodynamic or respiratory instability
ALL
No
Sponsors
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University of British Columbia
OTHER
Responsible Party
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David Wood
Professor
Principal Investigators
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David A Wood, MD
Role: PRINCIPAL_INVESTIGATOR
CCI-CIC, University of British Columbia
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Alex Vasquez, MD
Role: primary
Hursh Naik, MD
Role: primary
Celina Yong, MD
Role: primary
Ken Jutzy, MD
Role: primary
Michael Shenoda, MD
Role: primary
Salman Azam, MD
Role: primary
Mark Rothenberg, MD
Role: primary
Sidd Wayangankar, MD
Role: primary
Ramon Quesada
Role: primary
Pradeep Yadav, MD
Role: primary
Ronnie Ramadan
Role: primary
Joseph Walsh, MD
Role: primary
Andrei Pop, MD
Role: primary
Troy Weirick, MD
Role: primary
Roy W Robertson, MD
Role: primary
Peter Tadros, MD
Role: primary
Bangalore Deepak, MD
Role: primary
Bassem Chehab, MD
Role: primary
Charles Resor, MD
Role: primary
Nilay Patel, MD
Role: primary
Mohammad Qintar, MD
Role: primary
Amr Abbas, MD
Role: primary
Safwan Kassas, MD
Role: primary
Mansoor A Qureshi, MD
Role: primary
Gregory Helmer, MD
Role: primary
Thom Dahle, MD
Role: primary
Joss Fernandez, MD
Role: primary
Kishore Harjai, MD
Role: primary
Gus Theodos, MD
Role: primary
Matthew Johnson, MD
Role: primary
James DeVries, MD
Role: primary
Ibrahim Moussa, MD
Role: primary
Raj Tayal, MD
Role: primary
Vijay Iyer, MD
Role: primary
Richard Schwartz, DO
Role: primary
Samin Sharma, MD
Role: primary
Vivian Ng, MD
Role: primary
Ayman Iskander, MD
Role: primary
Mark Menegus, MD
Role: primary
Oluseun Alli, MD
Role: primary
Peter Bittenbender, MD
Role: primary
Noah Jones, MD
Role: primary
Mohammad Ghani, MD
Role: primary
Abhimanyu Uberoi
Role: primary
Paul Gordon, MD
Role: primary
Mehul Patel, MD
Role: primary
Mark Aziz, MD
Role: primary
Ayaz Rahman, MD
Role: primary
Basil Paulus, MD
Role: primary
Pranav Loyalka, MD
Role: primary
Srini Potluri, MD
Role: primary
Jose Condado, MD
Role: primary
Tanush Gupta, MD
Role: primary
Jason Ricci
Role: primary
Brad Stair, MD
Role: primary
Robert Welsh, MD
Role: primary
Albert Chan, MD
Role: primary
Jackie Chow
Role: primary
Elizabeth Grieve
Role: primary
Malek Kass, MD
Role: primary
Brent McGrath, MD
Role: primary
Osama ElKhateeb, MD
Role: primary
Tej Sheth, MD
Role: primary
Sandy Dick, MD
Role: primary
Sam Radhakrishnan
Role: primary
Neil Fam, MD
Role: primary
Anita Asgar, MD
Role: primary
Jean Bernard Masson
Role: primary
Rémi Kouz, MD
Role: primary
Benoit Daneault, MD
Role: primary
Payam Dehghani, MD
Role: primary
Other Identifiers
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H20-00968
Identifier Type: -
Identifier Source: org_study_id
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