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Aortic StenosisCOMPLETE TAVRNCT04634240

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

A study testing Percutaneous Coronary Intervention (PCI) in people with Aortic Stenosis and Coronary Artery Disease, run by University of British Columbia at 72 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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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. Read more about this study

Who is it for?
Any age
What is being tested?
Percutaneous Coronary Intervention (PCI)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,000 participants
Where
72 sitesin 2 countries
Study dates
19 Dec 2020to 1 Apr 2026
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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:
Show all 13Show fewer
  • [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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

72 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Brady J Robinson, CCRP contact

604-875-4111 ext. 22936

brobinson@cci-cic.org

72 sites in 2 countries

United States55 sites, 55 recruiting

  • Summa Health System

    Akron, Ohio, 44304

    Peter Bittenbender, MD

    Recruiting

  • Piedmont

    Atlanta, Georgia, 30309

    Pradeep Yadav, MD

    Recruiting

  • JFK Medical Center

    Atlantis, Florida, 33462

    Mark Rothenberg, MD

    Recruiting

  • St. Alphonsus Regional Medical Center

    Boise, Idaho, 83709

    Joseph Walsh, MD

    Recruiting

  • Tufts Medical

    Boston, Massachusetts, 02111

    Charles Resor, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Nilay Patel, MD

    Recruiting

  • University at Buffalo

    Buffalo, New York, 14203

    Vijay Iyer, MD

    Recruiting

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

    Tanush Gupta, MD

    Recruiting

  • Our Lady of Lourdes

    Camden, New Jersey, 08103

    Ibrahim Moussa, MD

    Recruiting

  • Novant Health Heart and Vascular Institute

    Charlotte, North Carolina, 28204

    Oluseun Alli, MD

    Recruiting

  • Ascension Alexian Brothers

    Chicago, Illinois, 60007

    Andrei Pop, MD

    Recruiting

  • Kaiser Permanente Northwest

    Clackamas, Oregon, 97015

    Abhimanyu Uberoi

    Recruiting

  • Boone Hospital

    Columbia, Missouri, 65201

    Joss Fernandez, MD

    Recruiting

  • Mount Carmel

    Columbus, Ohio, 43213

    Noah Jones, MD

    Recruiting

  • Midwest Cardiovascular Research and Education Foundation

    Elkhart, Indiana, 46514

    Troy Weirick, MD

    Recruiting

  • Parkview Research Center

    Fort Wayne, Indiana, 46845

    Roy W Robertson, MD

    Recruiting

  • Northeast Georgia Health System

    Gainesville, Georgia, 30501

    Ronnie Ramadan

    Recruiting

  • Methodist Le Bonheur Healthcare

    Germantown, Tennessee, 38138

    Mehul Patel, MD

    Recruiting

  • Bellin Health System

    Green Bay, Wisconsin, 54301

    Jason Ricci

    Recruiting

  • HCA Houston Healthcare Medical Center

    Houston, Texas, 77004

    Pranav Loyalka, MD

    Recruiting

  • Huntsville Heart Center

    Huntsville, Alabama, 35801

    Alex Vasquez, MD

    Recruiting

  • Baptist Health Jacksonville

    Jacksonville, Florida, 32207

    Sidd Wayangankar, MD

    Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

    Peter Tadros, MD

    Recruiting

  • Ballad Health CVA Heart Institute

    Kingsport, Tennessee, 37660

    Mark Aziz, MD

    Recruiting

  • Parkwest Medical Center

    Knoxville, Tennessee, 37923

    Ayaz Rahman, MD

    Recruiting

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48912

    Mohammad Qintar, MD

    Recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03765

    James DeVries, MD

    Recruiting

  • Bryan Heart

    Lincoln, Nebraska, 68506

    Matthew Johnson, MD

    Recruiting

  • Cardiovascular Surgery Clinic/Baptist Memorial

    Memphis, Tennessee, 38671

    Basil Paulus, MD

    Recruiting

  • Miami Cardiac and Vascular/Baptist Hospital

    Miami, Florida, 33139

    Ramon Quesada

    Recruiting

  • Ascension Columbia St. Mary's

    Milwaukee, Wisconsin, 53211

    Brad Stair, MD

    Recruiting

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501

    Richard Schwartz, DO

    Recruiting

  • University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455

    Gregory Helmer, MD

    Recruiting

  • Mount Sinai

    New York, New York, 10029

    Samin Sharma, MD

    Recruiting

  • Columbia University Medical Center

    New York, New York, 10552

    Vivian Ng, MD

    Recruiting

  • Oklahoma Heart

    Oklahoma City, Oklahoma, 73110

    Mohammad Ghani, MD

    Recruiting

  • Midwest Heart and Vascular

    Overland Park, Kansas, 66211

    Bangalore Deepak, MD

    Recruiting

  • Veteran Affairs Palo Alto Health Care System

    Palo Alto, California, 94304

    Celina Yong, MD

    Recruiting

  • Arizona Cardiovascular Research

    Phoenix, Arizona, 85027

    Hursh Naik, MD

    Recruiting

  • Baylor Scott & White Plano

    Plano, Texas, 75093

    Srini Potluri, MD

    Recruiting

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

    Paul Gordon, MD

    Recruiting

  • Loma Linda University

    Redlands, California, 92373

    Ken Jutzy, MD

    Recruiting

  • Valley Hospital

    Ridgewood, New Jersey, 07450

    Raj Tayal, MD

    Recruiting

  • Baylor Scott & White Round Rock

    Round Rock, Texas, 78665

    Jose Condado, MD

    Recruiting

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

    Amr Abbas, MD

    Recruiting

  • Ascension St. Mary's

    Saginaw, Michigan, 48197

    Safwan Kassas, MD

    Recruiting

  • CentraCare Heart and Vascular Center

    Saint Cloud, Minnesota, 56303

    Thom Dahle, MD

    Recruiting

  • Santa Barbara Cottage Hospital

    Santa Barbara, California, 93105

    Michael Shenoda, MD

    Recruiting

  • St. Louis University

    St Louis, Missouri, 63103

    Kishore Harjai, MD

    Recruiting

  • Missouri Baptist

    St Louis, Missouri, 63131

    Gus Theodos, MD

    Recruiting

  • St. Joseph's Hospital

    Syracuse, New York, 13088

    Ayman Iskander, MD

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467

    Mark Menegus, MD

    Recruiting

  • Torrance Memorial Medical Center

    Torrance, California, 90505

    Salman Azam, MD

    Recruiting

  • Cardiovascular Research Institute of Kansas

    Wichita, Kansas, 64131

    Bassem Chehab, MD

    Recruiting

  • St. Joseph Mercy Health System

    Ypsilanti, Michigan, 48197

    Mansoor A Qureshi, MD

    Recruiting

Other trials in United States

Canada17 sites, 17 recruiting

  • University of Alberta, Mazankowski Heart Institute

    Edmonton, Alberta, T6G 2B7

    Robert Welsh, MD

    Recruiting

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3H 3A7

    Osama ElKhateeb, MD

    Recruiting

  • Hamilton Health Sciences

    Hamilton, Ontario, L8L 2X2

    Tej Sheth, MD

    Recruiting

  • Montréal Heart

    Montreal, Quebec, H1T 1C8

    Anita Asgar, MD

    Recruiting

  • Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec, H2X 3E4

    Jean Bernard Masson

    Recruiting

  • Sacré-Coeur

    Montreal, Quebec, H4J 1C4

    Rémi Kouz, MD

    Recruiting

  • Royal Columbian Hospital

    New Westminster, British Columbia, V3L 3W7

    Albert Chan, MD

    Recruiting

  • Ottawa Heart

    Ottawa, Ontario, K1Y 4W7

    Sandy Dick, MD

    Recruiting

  • Prairie Vascular

    Regina, Saskatchewan, S4P 0W5

    Payam Dehghani, MD

    Recruiting

  • New Brunswick Heart

    Saint John, New Brunswick, E2L 4L2

    Brent McGrath, MD

    Recruiting

  • CIUSSS de l'Estrie-CHUS

    Sherbrooke, Quebec, J1H 5H3

    Benoit Daneault, MD

    Recruiting

  • Sunnybrook Hospital

    Toronto, Ontario, M4N 3M5

    Sam Radhakrishnan

    Recruiting

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

    Neil Fam, MD

    Recruiting

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

    Jackie Chow, 604-875-5324

    Recruiting

  • Centre for Cardiovascular Innovation-Centre d'Innovation Cardiovasculaire (CCI-CIC)

    Vancouver, British Columbia, V5Z1M9

    Brady J Robinson, CCRP, 604-875-4111 ext. 22936, brobinson@cci-cic.org

    David A Wood, MD

    Not yet recruiting

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

    Elizabeth Grieve, 604-682-2344 ext. 64980

    Recruiting

  • Saint Boniface

    Winnipeg, Manitoba, R2H 2A6

    Malek Kass, MD

    Recruiting

Other trials in Canada

About this study

Official title: 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

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.

Read more

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.

Being tested
Percutaneous Coronary Intervention (PCI)
Keywords
Transcatheter Aortic Valve Replacement, Percutaneous Coronary Intervention, Coronary Artery Disease, Aortic Stenosis
Medical subject headings
Aortic Valve Stenosis, Coronary Artery Disease, Coronary Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous Coronary Intervention (PCI)Procedure or surgery

    PCI of all qualifying lesions.

Study groups in NCT04634240
Study groupRoleWhat they receive
Complete RevascularizationExperimentalRoutine PCI (percutaneous coronary intervention) of all suitable coronary artery stenoses of ≥70% in vessels ≥2.5mm in diameter.
Receives: Procedure: Percutaneous Coronary Intervention (PCI)
Medical Therapy AloneNo interventionNo revascularization of coronary artery lesions.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite of Cardiovascular Death or New Myocardial Infarction or Ischemia-Driven Revascularization or Hospitalization for Unstable Angina or Heart Failure

    Measured: Median follow-up of 3.5 years

Secondary outcomes (20)

  1. 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.

    Measured: Median follow-up of 3.5 years

  2. Transaortic gradient immediately post-TAVR (echocardiographically-derived vs. direct invasive measurement)

    Measured: Immediately post-TAVR

  3. 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.

    Measured: Median follow-up of 3.5 years

  4. 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.

    Measured: Median follow-up of 3.5 years

  5. 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.

    Measured: Median follow-up of 3.5 years

  6. 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.

    Measured: Median follow-up of 3.5 years

  7. Composite outcome of mean echocardiographic gradient ≥ 20mmHg, severe PPM, ≥ moderate AR, thrombosis, endocarditis, and aortic valve re-intervention

    Measured: Median follow-up of 3.5 years

  8. Cardiovascular Death

    Measured: Median follow-up of 3.5 years

  9. New Myocardial Infarction

    Measured: Median follow-up of 3.5 years

  10. Ischemia-Driven Revascularization

    Measured: Median follow-up of 3.5 years

  11. Hospitalization for Unstable Angina or Heart Failure

    Measured: Median follow-up of 3.5 years

  12. All-cause Mortality

    Includes deaths from both cardiac and non-cardiac causes

    Measured: Median follow-up of 3.5 years

  13. 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.

    Measured: Median follow-up of 3.5 years

  14. 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

    Measured: Median follow-up of 3.5 years

  15. Angina status

    As evaluated by the Seattle Angina Questionnaire

    Measured: Median follow-up of 3.5 years

  16. Economic evaluation

    Includes health resource utilization, costs, and cost-effectiveness

    Measured: Median follow-up of 3.5 years

  17. 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.

    Measured: Median follow-up of 3.5 years

  18. 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.

    Measured: Median follow-up of 3.5 years

  19. Fluoroscopic time for Staged PCI procedure

    Total time under fluoroscopy

    Measured: During PCI procedure

  20. Contrast Utilization for Stages PCI Procedure

    Measured: During PCI procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2020
  2. Study start19 Dec 2020
  3. Primary completion1 Apr 2026 (estimated)
  4. Study completion1 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
4,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04634240
Sponsor's protocol ID
H20-00968
Acronym
COMPLETE TAVR
Status last verified
Jul 2025
First submitted
16 Nov 2020
Last updated
24 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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