Recruiting

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

Sponsor:

University of British Columbia

Code:

NCT04634240

Conditions

Aortic Stenosis

Coronary Artery Disease

Coronary Stenosis

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Percutaneous Coronary Intervention (PCI)

Study Details

Brief 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.

Conditions

Aortic Stenosis

Coronary Artery Disease

Coronary Stenosis

Study ID

NCT04634240

Start date

Dec 19, 2020

Status verified date

Jul, 2025

Completion date

Apr 1, 2026

Anticipated

Primary completion date

Apr 1, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

\- Symptomatic aortic valve stenosis prior to TAVR (NYHA Functional Class ≥ 2 OR Abnormal exercise test with severe SOB, abnormal BP response, or arrhythmia)

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:

PCI already performed within 90 days prior to TAVR or at the same time as the index transfemoral TAVR procedure
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

Study Design

Enrollment

4000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Complete Revascularization

Routine PCI (percutaneous coronary intervention) of all suitable coronary artery stenoses of ≥70% in vessels ≥2.5mm in diameter.

no intervention: Medical Therapy Alone

No revascularization of coronary artery lesions.

Interventions

Percutaneous Coronary Intervention (PCI)

PCI of all qualifying lesions.

Primary outcome measure

Composite of Cardiovascular Death or New Myocardial Infarction or Ischemia-Driven Revascularization or Hospitalization for Unstable Angina or Heart Failure [ Time Frame: Median follow-up of 3.5 years ]

Central Contacts and Locations

Central contacts

Brady J Robinson, CCRP

604-875-4111 brobinson@cci-cic.org

Locations

Huntsville Heart Center

Recruiting

Huntsville, Alabama, United States, 35801

Arizona Cardiovascular Research

Recruiting

Phoenix, Arizona, United States, 85027

Veteran Affairs Palo Alto Health Care System

Recruiting

Palo Alto, California, United States, 94304

Loma Linda University

Recruiting

Redlands, California, United States, 92373

Santa Barbara Cottage Hospital

Recruiting

Santa Barbara, California, United States, 93105

Torrance Memorial Medical Center

Recruiting

Torrance, California, United States, 90505

JFK Medical Center

Recruiting

Atlantis, Florida, United States, 33462

Baptist Health Jacksonville

Recruiting

Jacksonville, Florida, United States, 32207

Miami Cardiac and Vascular/Baptist Hospital

Recruiting

Miami, Florida, United States, 33139

Piedmont

Recruiting

Atlanta, Georgia, United States, 30309

Northeast Georgia Health System

Recruiting

Gainesville, Georgia, United States, 30501

St. Alphonsus Regional Medical Center

Recruiting

Boise, Idaho, United States, 83709

Ascension Alexian Brothers

Recruiting

Chicago, Illinois, United States, 60007

Midwest Cardiovascular Research and Education Foundation

Recruiting

Elkhart, Indiana, United States, 46514

Parkview Research Center

Recruiting

Fort Wayne, Indiana, United States, 46845

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Midwest Heart and Vascular

Recruiting

Overland Park, Kansas, United States, 66211

Cardiovascular Research Institute of Kansas

Recruiting

Wichita, Kansas, United States, 64131

Tufts Medical

Recruiting

Boston, Massachusetts, United States, 02111

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Sparrow Clinical Research Institute

Recruiting

Lansing, Michigan, United States, 48912

William Beaumont Hospital

Recruiting

Royal Oak, Michigan, United States, 48073

Ascension St. Mary's

Recruiting

Saginaw, Michigan, United States, 48197

St. Joseph Mercy Health System

Recruiting

Ypsilanti, Michigan, United States, 48197

University of Minnesota Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55455

CentraCare Heart and Vascular Center

Recruiting

Saint Cloud, Minnesota, United States, 56303

Boone Hospital

Recruiting

Columbia, Missouri, United States, 65201

St. Louis University

Recruiting

St Louis, Missouri, United States, 63103

Missouri Baptist

Recruiting

St Louis, Missouri, United States, 63131

Bryan Heart

Recruiting

Lincoln, Nebraska, United States, 68506

Dartmouth Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03765

Our Lady of Lourdes

Recruiting

Camden, New Jersey, United States, 08103

Valley Hospital

Recruiting

Ridgewood, New Jersey, United States, 07450

University at Buffalo

Recruiting

Buffalo, New York, United States, 14203

NYU Langone Hospital - Long Island

Recruiting

Mineola, New York, United States, 11501

Mount Sinai

Recruiting

New York, New York, United States, 10029

Columbia University Medical Center

Recruiting

New York, New York, United States, 10552

St. Joseph's Hospital

Recruiting

Syracuse, New York, United States, 13088

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Novant Health Heart and Vascular Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Summa Health System

Recruiting

Akron, Ohio, United States, 44304

Mount Carmel

Recruiting

Columbus, Ohio, United States, 43213

Oklahoma Heart

Recruiting

Oklahoma City, Oklahoma, United States, 73110

Kaiser Permanente Northwest

Recruiting

Clackamas, Oregon, United States, 97015

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Methodist Le Bonheur Healthcare

Recruiting

Germantown, Tennessee, United States, 38138

Ballad Health CVA Heart Institute

Recruiting

Kingsport, Tennessee, United States, 37660

Parkwest Medical Center

Recruiting

Knoxville, Tennessee, United States, 37923

Cardiovascular Surgery Clinic/Baptist Memorial

Recruiting

Memphis, Tennessee, United States, 38671

HCA Houston Healthcare Medical Center

Recruiting

Houston, Texas, United States, 77004

Baylor Scott & White Plano

Recruiting

Plano, Texas, United States, 75093

Baylor Scott & White Round Rock

Recruiting

Round Rock, Texas, United States, 78665

University of Vermont Medical Center

Recruiting

Burlington, Vermont, United States, 05401

Bellin Health System

Recruiting

Green Bay, Wisconsin, United States, 54301

Ascension Columbia St. Mary's

Recruiting

Milwaukee, Wisconsin, United States, 53211

University of Alberta, Mazankowski Heart Institute

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Royal Columbian Hospital

Recruiting

New Westminster, British Columbia, Canada, V3L 3W7

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Jackie Chow

604-875-5324

St. Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

Elizabeth Grieve

604-682-2344

Saint Boniface

Recruiting

Winnipeg, Manitoba, Canada, R2H 2A6

New Brunswick Heart

Recruiting

Saint John, New Brunswick, Canada, E2L 4L2

Queen Elizabeth II Health Sciences Centre

Recruiting

Halifax, Nova Scotia, Canada, B3H 3A7

Hamilton Health Sciences

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Ottawa Heart

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

Sunnybrook Hospital

Recruiting

Toronto, Ontario, Canada, M4N 3M5

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Montréal Heart

Recruiting

Montreal, Quebec, Canada, H1T 1C8

Centre Hospitalier de l'Université de Montréal

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Sacré-Coeur

Recruiting

Montreal, Quebec, Canada, H4J 1C4

CIUSSS de l'Estrie-CHUS

Recruiting

Sherbrooke, Quebec, Canada, J1H 5H3

Prairie Vascular

Recruiting

Regina, Saskatchewan, Canada, S4P 0W5

More Information

Sponsor

University of British Columbia

Last update posted

Jul 24, 2025

Last verified

Jul, 2025

Keywords

Transcatheter Aortic Valve Replacement
Percutaneous Coronary Intervention
Coronary Artery Disease
Aortic Stenosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of British Columbia on 2025-07-24.