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

Status: Recruiting
Location: See all (72) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• \- 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.

Locations
United States
Alabama
Huntsville Heart Center
RECRUITING
Huntsville
Arizona
Arizona Cardiovascular Research
RECRUITING
Phoenix
California
Veteran Affairs Palo Alto Health Care System
RECRUITING
Palo Alto
Loma Linda University
RECRUITING
Redlands
Santa Barbara Cottage Hospital
RECRUITING
Santa Barbara
Torrance Memorial Medical Center
RECRUITING
Torrance
Florida
JFK Medical Center
RECRUITING
Atlantis
Baptist Health Jacksonville
RECRUITING
Jacksonville
Miami Cardiac and Vascular/Baptist Hospital
RECRUITING
Miami
Georgia
Piedmont
RECRUITING
Atlanta
Northeast Georgia Health System
RECRUITING
Gainesville
Idaho
St. Alphonsus Regional Medical Center
RECRUITING
Boise
Illinois
Ascension Alexian Brothers
RECRUITING
Chicago
Indiana
Midwest Cardiovascular Research and Education Foundation
RECRUITING
Elkhart
Parkview Research Center
RECRUITING
Fort Wayne
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Midwest Heart and Vascular
RECRUITING
Overland Park
Cardiovascular Research Institute of Kansas
RECRUITING
Wichita
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Tufts Medical
RECRUITING
Boston
Michigan
Sparrow Clinical Research Institute
RECRUITING
Lansing
William Beaumont Hospital
RECRUITING
Royal Oak
Ascension St. Mary's
RECRUITING
Saginaw
St. Joseph Mercy Health System
RECRUITING
Ypsilanti
Minnesota
University of Minnesota Medical Center
RECRUITING
Minneapolis
CentraCare Heart and Vascular Center
RECRUITING
Saint Cloud
Missouri
Boone Hospital
RECRUITING
Columbia
Missouri Baptist
RECRUITING
St Louis
St. Louis University
RECRUITING
St Louis
North Carolina
Novant Health Heart and Vascular Institute
RECRUITING
Charlotte
Nebraska
Bryan Heart
RECRUITING
Lincoln
New Hampshire
Dartmouth Hitchcock Medical Center
RECRUITING
Lebanon
New Jersey
Our Lady of Lourdes
RECRUITING
Camden
Valley Hospital
RECRUITING
Ridgewood
New York
University at Buffalo
RECRUITING
Buffalo
NYU Langone Hospital - Long Island
RECRUITING
Mineola
Columbia University Medical Center
RECRUITING
New York
Mount Sinai
RECRUITING
New York
St. Joseph's Hospital
RECRUITING
Syracuse
Montefiore Medical Center
RECRUITING
The Bronx
Ohio
Summa Health System
RECRUITING
Akron
Mount Carmel
RECRUITING
Columbus
Oklahoma
Oklahoma Heart
RECRUITING
Oklahoma City
Oregon
Kaiser Permanente Northwest
RECRUITING
Clackamas
Rhode Island
Rhode Island Hospital
RECRUITING
Providence
Tennessee
Methodist Le Bonheur Healthcare
RECRUITING
Germantown
Ballad Health CVA Heart Institute
RECRUITING
Kingsport
Parkwest Medical Center
RECRUITING
Knoxville
Cardiovascular Surgery Clinic/Baptist Memorial
RECRUITING
Memphis
Texas
HCA Houston Healthcare Medical Center
RECRUITING
Houston
Baylor Scott & White Plano
RECRUITING
Plano
Baylor Scott & White Round Rock
RECRUITING
Round Rock
Vermont
University of Vermont Medical Center
RECRUITING
Burlington
Wisconsin
Bellin Health System
RECRUITING
Green Bay
Ascension Columbia St. Mary's
RECRUITING
Milwaukee
Other Locations
Canada
University of Alberta, Mazankowski Heart Institute
RECRUITING
Edmonton
Queen Elizabeth II Health Sciences Centre
RECRUITING
Halifax
Hamilton Health Sciences
RECRUITING
Hamilton
Centre Hospitalier de l'Université de Montréal
RECRUITING
Montreal
Montréal Heart
RECRUITING
Montreal
Sacré-Coeur
RECRUITING
Montreal
Royal Columbian Hospital
RECRUITING
New Westminster
Ottawa Heart
RECRUITING
Ottawa
Prairie Vascular
RECRUITING
Regina
New Brunswick Heart
RECRUITING
Saint John
CIUSSS de l'Estrie-CHUS
RECRUITING
Sherbrooke
St. Michael's Hospital
RECRUITING
Toronto
Sunnybrook Hospital
RECRUITING
Toronto
Centre for Cardiovascular Innovation-Centre d'Innovation Cardiovasculaire (CCI-CIC)
NOT_YET_RECRUITING
Vancouver
St. Paul's Hospital
RECRUITING
Vancouver
Vancouver General Hospital
RECRUITING
Vancouver
Saint Boniface
RECRUITING
Winnipeg
Contact Information
Primary
Brady J Robinson, CCRP
brobinson@cci-cic.org
604-875-4111
Time Frame
Start Date: 2020-12-19
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 4000
Treatments
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.
Sponsors
Leads: University of British Columbia

This content was sourced from clinicaltrials.gov

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