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Comparing heart surgery and medical management for patients with aortic stenosis and coronary artery disease

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

NA · University of British Columbia · NCT04634240

This study is testing whether combining heart surgery with medical treatment is better for patients who have both aortic stenosis and coronary artery disease.

Quick facts

PhaseNA
Study typeInterventional
Enrollment4000 (estimated)
SexAll
SponsorUniversity of British Columbia (other)
Locations72 sites (Huntsville, Alabama and 71 other locations)
Trial IDNCT04634240 on ClinicalTrials.gov

What this trial studies

This study investigates the outcomes of patients with symptomatic aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) who also have coronary artery disease (CAD). It aims to determine the benefits and optimal timing of percutaneous coronary intervention (PCI) in conjunction with guideline-directed medical therapy. The study will compare a strategy of staged complete revascularization against medical management alone to assess which approach yields better patient outcomes. The findings will help clarify the management of CAD in patients receiving TAVR, especially as this procedure becomes more common in lower-risk populations.

Who should consider this trial

Good fit: Ideal candidates include patients with symptomatic aortic stenosis and significant coronary artery disease who are suitable for TAVR.

Not a fit: Patients without significant coronary artery disease or those not eligible for TAVR may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment strategies for patients with aortic stenosis and coronary artery disease, potentially leading to better heart health outcomes.

How similar studies have performed: Other studies have explored similar interventions in cardiac patients, but this specific approach regarding TAVR and CAD management is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Huntsville, Alabama and 71 other locations

+22 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Aortic Stenosis, Coronary Artery Disease, Coronary Stenosis, Transcatheter Aortic Valve Replacement, Percutaneous Coronary Intervention

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.