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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04634240
Other study ID # H20-00968
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 19, 2020
Est. completion date April 1, 2026

Study information

Verified date December 2023
Source University of British Columbia
Contact Brady J Robinson, CCRP
Phone 604-875-4111
Email brobinson@cci-cic.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 4000
Est. completion date April 1, 2026
Est. primary completion date April 1, 2026
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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


Intervention

Procedure:
Percutaneous Coronary Intervention (PCI)
PCI of all qualifying lesions.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Composite of Cardiovascular Death or New Myocardial Infarction or Ischemia-Driven Revascularization or Hospitalization for Unstable Angina or Heart Failure Median follow-up of 3.5 years
Secondary Cardiovascular Death or New Myocardial Infarction Deaths will be classified as cardiovascular or non-cardiovascular. All deaths with a clear cardiovascular or unknown cause, will be classified as cardiovascular. However, within cardiovascular deaths, hemorrhagic deaths will be clearly identified. Only deaths due to a documented non-cardiovascular cause (e.g., cancer) will be classified as non-cardiovascular.
Myocardial Infarction will be defined according to the 4th Universal Definition of Myocardial Infarction, with modification for Type 4a (PCI-related) and Type 5 (CABG-related) as defined for the ISCHEMIA trial and as used in the COMPLETE trial.
Median follow-up of 3.5 years
Secondary Transaortic gradient immediately post-TAVR (echocardiographically-derived vs. direct invasive measurement) Immediately post-TAVR
Secondary Transaortic Gradient Reclassification Proportion of patients developing echocardiographic aortic gradient =20 mmHg who are found to have a gradient < 20 mmHg on direct hemodynamic assessment. Median follow-up of 3.5 years
Secondary VARC-3 Hemodynamic Valve Deterioration Reclassification Proportion of patients developing = moderate echocardiographic VARC-3 valve deterioration reclassified to < moderate VARC-3 valve deterioration using direct invasive methods, including mean gradient and valve area. Median follow-up of 3.5 years
Secondary Severe Patient Prosthesis Mismatch (PPM) Reclassification Proportion of patients with echocardiographic severe PPM immediately post-TAVR, reclassified as non-severe PPM using direct invasive methods. Median follow-up of 3.5 years
Secondary Composite of CV Death, New MI, IDR or Hospitalization for UA or for HF in patients with PPM and elevated gradients vs those without Deaths: will be classified as cardiovascular or non-cardiovascular. All deaths with a clear cardiovascular or unknown cause, will be classified as cardiovascular. However, within cardiovascular deaths, hemorrhagic deaths will be clearly identified. Only deaths due to a documented non-cardiovascular cause (e.g., cancer) will be classified as non-cardiovascular.
Myocardial Infarction: will be defined according to the 4th Universal Definition of Myocardial Infarction, with modification for Type 4a (PCI-related) and Type 5 (CABG-related) as defined for the ISCHEMIA trial and as used in the COMPLETE trial.
Hospital admission: for protocol-defined unstable angina, new/worsening NYHA Class IV heart failure, or for protocol-defined Ischemia-driven revascularization, among patients with patient prosthesis mismatch (PPM), elevated echocardiography-derived transaortic gradients and elevated direct invasive transaortic gradient vs those without.
Median follow-up of 3.5 years
Secondary Composite outcome of mean echocardiographic gradient = 20mmHg, severe PPM, = moderate AR, thrombosis, endocarditis, and aortic valve re-intervention Median follow-up of 3.5 years
Secondary Cardiovascular Death Median follow-up of 3.5 years
Secondary New Myocardial Infarction Median follow-up of 3.5 years
Secondary Ischemia-Driven Revascularization Median follow-up of 3.5 years
Secondary Hospitalization for Unstable Angina or Heart Failure Median follow-up of 3.5 years
Secondary All-cause Mortality Includes deaths from both cardiac and non-cardiac causes Median follow-up of 3.5 years
Secondary Stroke Defined as the presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting more than 24 hours. It is strongly recommended (but not required) that an imaging procedure such as CT scan or MRI be performed. Stroke will be further classified as ischemic, hemorrhagic or type uncertain. Median follow-up of 3.5 years
Secondary Bleeding Clinically overt, symptomatic bleeding with at least one of the following criteria:
Fatal, or
Symptomatic intracranial hemorrhage, or
Retroperitoneal hemorrhage, or
Intraocular hemorrhage leading to significant vision loss, or
Decrease in hemoglobin of 3.0 g/dL (with each blood transfusion unit counting for 1.0 g/dL of Hb) or requiring transfusion of two or more units of red blood cells or equivalent of whole blood.
Requiring surgical intervention to stop the bleeding
Median follow-up of 3.5 years
Secondary Angina status As evaluated by the Seattle Angina Questionnaire Median follow-up of 3.5 years
Secondary Economic evaluation Includes health resource utilization, costs, and cost-effectiveness Median follow-up of 3.5 years
Secondary Patient-reported outcomes Health-related quality of life as evaluated by the Kansas City Cardiomyopathy Questionnaire at baseline, 30 days, 6 months, 1 year, and annually thereafter. Median follow-up of 3.5 years
Secondary Contrast-associated acute kidney injury An absolute rise in serum creatinine of greater than or equal to 44 µmol/L from baseline and/or a relative rise in serum creatinine of =25% compared to baseline at any time between 48hrs and 96hrs post-procedure. Median follow-up of 3.5 years
Secondary Fluoroscopic time for Staged PCI procedure Total time under fluoroscopy During PCI procedure
Secondary Contrast Utilization for Stages PCI Procedure During PCI procedure
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