Testing Percutaneous Coronary Intervention for aortic stenosis
Official title: Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement
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
- 2 groups
- Sites in Edmonton, New Westminster and 10 more cities
- Recruiting
Interventions
- Medical procedure
Percutaneous Coronary Intervention (PCI)
PCI of all qualifying lesions.
Canadian Sites (17)
16 of 17 recruiting
- Recruiting
University of Alberta, Mazankowski Heart Institute
Edmonton, Alberta
- Recruiting
Royal Columbian Hospital
New Westminster, British Columbia
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia
- Recruiting
St. Paul's Hospital
Vancouver, British Columbia
- Recruiting
Saint Boniface
Winnipeg, Manitoba
- Recruiting
New Brunswick Heart
Saint John, New Brunswick
- Recruiting
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia
- Recruiting
Hamilton Health Sciences
Hamilton, Ontario
- Recruiting
Ottawa Heart
Ottawa, Ontario
- Recruiting
Sunnybrook Hospital
Toronto, Ontario
- Recruiting
St. Michael's Hospital
Toronto, Ontario
- Recruiting
Montréal Heart
Montreal, Quebec
- Recruiting
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec
- Recruiting
Sacré-Coeur
Montreal, Quebec
- Recruiting
CIUSSS de l'Estrie-CHUS
Sherbrooke, Quebec
- Recruiting
Prairie Vascular
Regina, Saskatchewan
- Not yet recruiting
Centre for Cardiovascular Innovation-Centre d'Innovation Cardiovasculaire (CCI-CIC)
Vancouver, British Columbia
Eligibility Criteria
See who this study is looking for21 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +\- Symptomatic aortic valve stenosis prior to TAVR (NYHA Functional Class ≥ 2 OR Abnormal exercise test with severe SOB, abnormal BP response, or arrhythmia)
- +\- 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
- +\- 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:
- +\[AVA ≤ 1.0 cm2 OR AVA index ≤ 0.6 cm2/m2\]
- +\[Jet velocity ≥ 4.0 m/s OR mean gradient ≥ 40 mmHg\]
- +patients without these criteria may undergo TAVR if the Local Multidisciplinary Heart Team concludes it is appropriate.
- +\- 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
- −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-upFollow-upContinued check-ins after the treatment part is finished.Read more →
- −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
- −Prior coronary artery bypass grafting surgery or surgical valve replacement
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Percutaneous Coronary Intervention (PCI).
Registry label: A: Complete Revascularization
Group B receives no study treatment and is followed for comparison.
Registry label: B: Medical Therapy Alone
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment at all, and is followed for comparison.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 4,000 people.
The study is currently expected to finish around April 2026.
The main measurement is taken over: Median follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → of 3.5 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Composite of Cardiovascular Death or New Myocardial Infarction or Ischemia-Driven Revascularization or Hospitalization for Unstable Angina or Heart Failure — measured over Median follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → of 3.5 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04634240 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Percutaneous Coronary Intervention (PCI)Procedure
PCI of all qualifying lesions.
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment and is followed for comparison.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Median follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → of 3.5 years.
The study as a whole is currently expected to finish around 2026-04-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 4,000 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 23 locations, including: Edmonton, Alberta, Canada; New Westminster, British Columbia, Canada; Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; Saint John, New Brunswick, Canada; Halifax, Nova Scotia, Canada, and 17 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (12)
Sparrow Clinical Research Institute
Lansing, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Ascension St. Mary's
Saginaw, Michigan, United States
St. Joseph Mercy Health System
Ypsilanti, Michigan, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota, United States
University at Buffalo
Buffalo, New York, United States
NYU Langone Hospital - Long Island
Mineola, New York, United States
Mount Sinai
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
St. Joseph's Hospital
Syracuse, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.