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Staged Complete Revascularization for Coronary Artery Disease in TAVR Patients

This study is looking at the best way to treat people who have both severe aortic valve narrowing (aortic stenosis) and blockages in their heart arteries (coronary artery disease) and are having a procedure called TAVR (Transcatheter Aortic Valve Replacement). Researchers want to compare two approaches: treating the blockages with a procedure called Percutaneous Coronary Intervention (PCI) versus managing them with medications alone. The main goal is to see if one approach is better at preventing serious heart problems like heart attack, heart failure, or death over about 3.5 years. You might be able to join if you have symptomatic aortic stenosis before TAVR and at least one significant blockage in your coronary arteries. The study plans to enroll 4000 participants.

Study design
This is an interventional study comparing two treatment strategies for coronary artery disease in patients undergoing TAVR. It aims to enroll 4000 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for a median of 3.5 years to track heart-related events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04634240

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

Recruiting
NAAll AgesInterventionalTreatment
University of British Columbia
~4,000 participants
Updated 2025-07-24 on ClinicalTrials.gov
What's tested:Percutaneous Coronary Intervention (PCI)

At a glance

Recruiting sites
71 of 72 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite of Cardiovascular Death or New Myocardial Infarction or Ischemia-Driven Revascularization or Hospitalization for Unstable Angina or Heart Failure
Measured over Median follow-up of 3.5 years

Conditions

Aortic Stenosis
Coronary Artery Disease
Coronary Stenosis

Explore related trials

Aortic Valve StenosisCoronary Artery Disease

Where it's being run

72 sites across 34 states
New York6
California4
Michigan4
Tennessee4
British Columbia4
Ontario4
Quebec4
Florida3

Study leadership

  • David A Wood, MD · PRINCIPAL_INVESTIGATOR · CCI-CIC, University of British Columbia

Who to contact

Brady J Robinson, CCRP
[email protected]
604-875-4111 · ext. 22936
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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-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

What this trial measures

  • Composite of Cardiovascular Death or New Myocardial Infarction or Ischemia-Driven Revascularization or Hospitalization for Unstable Angina or Heart FailureMedian follow-up of 3.5 years