Actively Recruiting
Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement
Led by University of British Columbia · Updated on 2025-07-24
4000
Participants Needed
72
Research Sites
275 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic aortic valve stenosis before TAVR with NYHA Class 2 or higher or abnormal exercise test with severe shortness of breath, abnormal blood pressure response, or arrhythmia
- Coronary artery disease with at least one coronary artery lesion with 70% or more diameter narrowing in a native vessel 2.5 mm or larger, not a chronic total occlusion, and suitable for PCI
- Local Heart Team agrees patient is suitable for elective transfemoral TAVR with balloon expandable valve and would need bypass grafting distal to lesions if undergoing surgical valve replacement
- Successful transfemoral TAVR within past 96 hours without major complications
You will not qualify if you...
- PCI performed within 90 days before or during the index TAVR procedure
- Planned PCI or surgical revascularization of coronary artery lesions
- Non-cardiac illness limiting life expectancy to less than 5 years
- Any reason preventing 5-year follow-up
- Prior coronary artery bypass grafting or surgical valve replacement
- Severe mitral valve leakage (greater than 3+)
- Severe left ventricular dysfunction (ejection fraction less than 30%)
- Low coronary artery origin with high risk for obstruction
- Heart attack or stroke within past 90 days
- Severe kidney failure (eGFR less than 30 ml/min) or need for dialysis
- Unstable heart or breathing status
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 72 locations
1
Huntsville Heart Center
Huntsville, Alabama, United States, 35801
Actively Recruiting
2
Arizona Cardiovascular Research
Phoenix, Arizona, United States, 85027
Actively Recruiting
3
Veteran Affairs Palo Alto Health Care System
Palo Alto, California, United States, 94304
Actively Recruiting
4
Loma Linda University
Redlands, California, United States, 92373
Actively Recruiting
5
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93105
Actively Recruiting
6
Torrance Memorial Medical Center
Torrance, California, United States, 90505
Actively Recruiting
7
JFK Medical Center
Atlantis, Florida, United States, 33462
Actively Recruiting
8
Baptist Health Jacksonville
Jacksonville, Florida, United States, 32207
Actively Recruiting
9
Miami Cardiac and Vascular/Baptist Hospital
Miami, Florida, United States, 33139
Actively Recruiting
10
Piedmont
Atlanta, Georgia, United States, 30309
Actively Recruiting
11
Northeast Georgia Health System
Gainesville, Georgia, United States, 30501
Actively Recruiting
12
St. Alphonsus Regional Medical Center
Boise, Idaho, United States, 83709
Actively Recruiting
13
Ascension Alexian Brothers
Chicago, Illinois, United States, 60007
Actively Recruiting
14
Midwest Cardiovascular Research and Education Foundation
Elkhart, Indiana, United States, 46514
Actively Recruiting
15
Parkview Research Center
Fort Wayne, Indiana, United States, 46845
Actively Recruiting
16
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
17
Midwest Heart and Vascular
Overland Park, Kansas, United States, 66211
Actively Recruiting
18
Cardiovascular Research Institute of Kansas
Wichita, Kansas, United States, 64131
Actively Recruiting
19
Tufts Medical
Boston, Massachusetts, United States, 02111
Actively Recruiting
20
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
21
Sparrow Clinical Research Institute
Lansing, Michigan, United States, 48912
Actively Recruiting
22
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Actively Recruiting
23
Ascension St. Mary's
Saginaw, Michigan, United States, 48197
Actively Recruiting
24
St. Joseph Mercy Health System
Ypsilanti, Michigan, United States, 48197
Actively Recruiting
25
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
26
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota, United States, 56303
Actively Recruiting
27
Boone Hospital
Columbia, Missouri, United States, 65201
Actively Recruiting
28
St. Louis University
St Louis, Missouri, United States, 63103
Actively Recruiting
29
Missouri Baptist
St Louis, Missouri, United States, 63131
Actively Recruiting
30
Bryan Heart
Lincoln, Nebraska, United States, 68506
Actively Recruiting
31
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03765
Actively Recruiting
32
Our Lady of Lourdes
Camden, New Jersey, United States, 08103
Actively Recruiting
33
Valley Hospital
Ridgewood, New Jersey, United States, 07450
Actively Recruiting
34
University at Buffalo
Buffalo, New York, United States, 14203
Actively Recruiting
35
NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
Actively Recruiting
36
Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
37
Columbia University Medical Center
New York, New York, United States, 10552
Actively Recruiting
38
St. Joseph's Hospital
Syracuse, New York, United States, 13088
Actively Recruiting
39
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
40
Novant Health Heart and Vascular Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
41
Summa Health System
Akron, Ohio, United States, 44304
Actively Recruiting
42
Mount Carmel
Columbus, Ohio, United States, 43213
Actively Recruiting
43
Oklahoma Heart
Oklahoma City, Oklahoma, United States, 73110
Actively Recruiting
44
Kaiser Permanente Northwest
Clackamas, Oregon, United States, 97015
Actively Recruiting
45
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
46
Methodist Le Bonheur Healthcare
Germantown, Tennessee, United States, 38138
Actively Recruiting
47
Ballad Health CVA Heart Institute
Kingsport, Tennessee, United States, 37660
Actively Recruiting
48
Parkwest Medical Center
Knoxville, Tennessee, United States, 37923
Actively Recruiting
49
Cardiovascular Surgery Clinic/Baptist Memorial
Memphis, Tennessee, United States, 38671
Actively Recruiting
50
HCA Houston Healthcare Medical Center
Houston, Texas, United States, 77004
Actively Recruiting
51
Baylor Scott & White Plano
Plano, Texas, United States, 75093
Actively Recruiting
52
Baylor Scott & White Round Rock
Round Rock, Texas, United States, 78665
Actively Recruiting
53
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Actively Recruiting
54
Bellin Health System
Green Bay, Wisconsin, United States, 54301
Actively Recruiting
55
Ascension Columbia St. Mary's
Milwaukee, Wisconsin, United States, 53211
Actively Recruiting
56
University of Alberta, Mazankowski Heart Institute
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
57
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L 3W7
Actively Recruiting
58
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
59
Centre for Cardiovascular Innovation-Centre d'Innovation Cardiovasculaire (CCI-CIC)
Vancouver, British Columbia, Canada, V5Z1M9
Not Yet Recruiting
60
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Actively Recruiting
61
Saint Boniface
Winnipeg, Manitoba, Canada, R2H 2A6
Actively Recruiting
62
New Brunswick Heart
Saint John, New Brunswick, Canada, E2L 4L2
Actively Recruiting
63
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Actively Recruiting
64
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2
Actively Recruiting
65
Ottawa Heart
Ottawa, Ontario, Canada, K1Y 4W7
Actively Recruiting
66
Sunnybrook Hospital
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
67
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Actively Recruiting
68
Montréal Heart
Montreal, Quebec, Canada, H1T 1C8
Actively Recruiting
69
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2X 3E4
Actively Recruiting
70
Sacré-Coeur
Montreal, Quebec, Canada, H4J 1C4
Actively Recruiting
71
CIUSSS de l'Estrie-CHUS
Sherbrooke, Quebec, Canada, J1H 5H3
Actively Recruiting
72
Prairie Vascular
Regina, Saskatchewan, Canada, S4P 0W5
Actively Recruiting
Research Team
B
Brady J Robinson, CCRP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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