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

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
University of British Columbia
Study ID
NCT04634240
Status
Recruiting
Apply to this trial

Conditions

  • Aortic Stenosis
  • Coronary Artery Disease
  • Coronary Stenosis

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Percutaneous Coronary Intervention (PCI) — PROCEDURE
    PCI of all qualifying lesions.

Study Details

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.

Key Dates

Start date
Dec 19, 2020
Status verified
Jul 2025
Primary completion
Apr 1, 2026
Completion
Apr 1, 2026

Study Design

Enrollment
4,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (55)

FacilityCityStateZIPSite coordinators
Huntsville Heart CenterHuntsvilleAlabama35801
Alex Vasquez, MD
Arizona Cardiovascular ResearchPhoenixArizona85027
Hursh Naik, MD
Veteran Affairs Palo Alto Health Care SystemPalo AltoCalifornia94304
Celina Yong, MD
Loma Linda UniversityRedlandsCalifornia92373
Ken Jutzy, MD
Santa Barbara Cottage HospitalSanta BarbaraCalifornia93105
Michael Shenoda, MD
Torrance Memorial Medical CenterTorranceCalifornia90505
Salman Azam, MD
JFK Medical CenterAtlantisFlorida33462
Mark Rothenberg, MD
Baptist Health JacksonvilleJacksonvilleFlorida32207
Sidd Wayangankar, MD
Miami Cardiac and Vascular/Baptist HospitalMiamiFlorida33139
Ramon Quesada
PiedmontAtlantaGeorgia30309
Pradeep Yadav, MD
Northeast Georgia Health SystemGainesvilleGeorgia30501
Ronnie Ramadan
St. Alphonsus Regional Medical CenterBoiseIdaho83709
Joseph Walsh, MD
Ascension Alexian BrothersChicagoIllinois60007
Andrei Pop, MD
Midwest Cardiovascular Research and Education FoundationElkhartIndiana46514
Troy Weirick, MD
Parkview Research CenterFort WayneIndiana46845
Roy W Robertson, MD
University of Kansas Medical CenterKansas CityKansas66160
Peter Tadros, MD
Midwest Heart and VascularOverland ParkKansas66211
Bangalore Deepak, MD
Cardiovascular Research Institute of KansasWichitaKansas64131
Bassem Chehab, MD
Massachusetts General HospitalBostonMassachusetts02114
Nilay Patel, MD
Tufts MedicalBostonMassachusetts02111
Charles Resor, MD
Sparrow Clinical Research InstituteLansingMichigan48912
Mohammad Qintar, MD
William Beaumont HospitalRoyal OakMichigan48073
Amr Abbas, MD
Ascension St. Mary'sSaginawMichigan48197
Safwan Kassas, MD
St. Joseph Mercy Health SystemYpsilantiMichigan48197
Mansoor A Qureshi, MD
University of Minnesota Medical CenterMinneapolisMinnesota55455
Gregory Helmer, MD
CentraCare Heart and Vascular CenterSaint CloudMinnesota56303
Thom Dahle, MD
Boone HospitalColumbiaMissouri65201
Joss Fernandez, MD
Missouri BaptistSt LouisMissouri63131
Gus Theodos, MD
St. Louis UniversitySt LouisMissouri63103
Kishore Harjai, MD
Bryan HeartLincolnNebraska68506
Matthew Johnson, MD
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03765
James DeVries, MD
Our Lady of LourdesCamdenNew Jersey08103
Ibrahim Moussa, MD
Valley HospitalRidgewoodNew Jersey07450
Raj Tayal, MD
University at BuffaloBuffaloNew York14203
Vijay Iyer, MD
NYU Langone Hospital - Long IslandMineolaNew York11501
Richard Schwartz, DO
Columbia University Medical CenterNew YorkNew York10552
Vivian Ng, MD
Mount SinaiNew YorkNew York10029
Samin Sharma, MD
St. Joseph's HospitalSyracuseNew York13088
Ayman Iskander, MD
Montefiore Medical CenterThe BronxNew York10467
Mark Menegus, MD
Novant Health Heart and Vascular InstituteCharlotteNorth Carolina28204
Oluseun Alli, MD
Summa Health SystemAkronOhio44304
Peter Bittenbender, MD
Mount CarmelColumbusOhio43213
Noah Jones, MD
Oklahoma HeartOklahoma CityOklahoma73110
Mohammad Ghani, MD
Kaiser Permanente NorthwestClackamasOregon97015
Abhimanyu Uberoi
Rhode Island HospitalProvidenceRhode Island02903
Paul Gordon, MD
Methodist Le Bonheur HealthcareGermantownTennessee38138
Mehul Patel, MD
Ballad Health CVA Heart InstituteKingsportTennessee37660
Mark Aziz, MD
Parkwest Medical CenterKnoxvilleTennessee37923
Ayaz Rahman, MD
Cardiovascular Surgery Clinic/Baptist MemorialMemphisTennessee38671
Basil Paulus, MD
HCA Houston Healthcare Medical CenterHoustonTexas77004
Pranav Loyalka, MD
Baylor Scott & White PlanoPlanoTexas75093
Srini Potluri, MD
Baylor Scott & White Round RockRound RockTexas78665
Jose Condado, MD
University of Vermont Medical CenterBurlingtonVermont05401
Tanush Gupta, MD
Bellin Health SystemGreen BayWisconsin54301
Jason Ricci
Ascension Columbia St. Mary'sMilwaukeeWisconsin53211
Brad Stair, MD

Find similar trials in Huntsville, AL

By research site
Huntsville Heart Center· Huntsville, ALArizona Cardiovascular Research· Phoenix, AZVeteran Affairs Palo Alto Health Care System· Palo Alto, CALoma Linda University· Redlands, CASanta Barbara Cottage Hospital· Santa Barbara, CATorrance Memorial Medical Center· Torrance, CA

Related Studies