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Procedure

PCI vs Medical Management for Aortic Stenosis (COMPLETE TAVR Trial)

N/A
Recruiting
Led By David A Wood, MD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Consensus by the Multidisciplinary Heart Team that the patient is suitable for elective transfemoral transcatheter aortic valve replacement (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 surgical aortic valve replacement
Successful 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up median follow-up of 3.5 years
Awards & highlights

COMPLETE TAVR Trial Summary

This trial will compare the outcomes of two different strategies for managing concomitant CAD in patients undergoing TAVR: complete revascularization vs. medical therapy alone.

Who is the study for?
This trial is for men and women with severe symptomatic aortic valve stenosis who have undergone successful TAVR within the past 96 hours. They must have at least one treatable coronary artery lesion and be deemed suitable for elective transfemoral TAVR by a heart team. Exclusions include recent heart attacks or strokes, severe mitral regurgitation, life expectancy under 5 years, prior bypass surgery or valve replacement, among others.Check my eligibility
What is being tested?
The study tests if complete revascularization using drug eluting stents after TAVR (staged PCI) is better than just medical therapy alone in reducing cardiovascular death and other complications. Patients are randomly assigned to either undergo staged PCI post-TAVR or receive only medical management without further revascularization.See study design
What are the potential side effects?
Potential side effects of percutaneous coronary intervention (PCI) may include bleeding at the catheter insertion site, blood vessel damage, arrhythmias (irregular heartbeats), kidney damage from contrast dye used during the procedure, and rare cases of stroke or heart attack.

COMPLETE TAVR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart team agrees I can have a specific heart valve replacement through my thigh and would get a bypass if I had surgery.
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I had a successful heart valve replacement via catheter within the last 4 days without major issues.
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I have a significant blockage in one of my heart's arteries that can be treated without surgery.
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I have severe aortic valve stenosis with significant symptoms or test results.

COMPLETE TAVR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~median follow-up of 3.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and median follow-up of 3.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite of Cardiovascular Death or New Myocardial Infarction or Ischemia-Driven Revascularization or Hospitalization for Unstable Angina or Heart Failure
Secondary outcome measures
All-cause Mortality
Angina status
Bleeding
+17 more

COMPLETE TAVR Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Complete RevascularizationExperimental Treatment1 Intervention
Routine PCI (percutaneous coronary intervention) of all suitable coronary artery stenoses of ≥70% in vessels ≥2.5mm in diameter.
Group II: Medical Therapy AloneActive Control1 Intervention
No revascularization of coronary artery lesions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Percutaneous Coronary Intervention (PCI)
2019
Completed Phase 3
~1190

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,410 Previous Clinical Trials
1,762,609 Total Patients Enrolled
9 Trials studying Coronary Artery Disease
12,350 Patients Enrolled for Coronary Artery Disease
David A Wood, MDPrincipal InvestigatorCCI-CIC, University of British Columbia
2 Previous Clinical Trials
726 Total Patients Enrolled

Media Library

Percutaneous Coronary Intervention (PCI) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04634240 — N/A
Coronary Artery Disease Research Study Groups: Complete Revascularization, Medical Therapy Alone
Coronary Artery Disease Clinical Trial 2023: Percutaneous Coronary Intervention (PCI) Highlights & Side Effects. Trial Name: NCT04634240 — N/A
Percutaneous Coronary Intervention (PCI) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04634240 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for prospective participants to take part in this clinical investigation?

"Affirmative. According to the clinicaltrials.gov portal, this experiment is currently recruiting volunteers. It was first advertised on December 19th of 2020 and most recently updated on March 31st 2022 with a goal to secure 4000 participants from 26 separate locations."

Answered by AI

To what extent is the recruitment process for this clinical trial progressing?

"Affirmative, according to clinicaltrials.gov's database this research is actively recruiting. This investigation was initially posted on December 19th 2020 and has been recently modified on March 31st 2022. 4000 patients are necessary for the trial at 26 centers across the country."

Answered by AI

Where are the primary venues of this clinical experiment?

"This clinical trial has recruited participants from a total of 26 sites, such as St. Joseph Mercy Health System in Ypsilanti, University of Minnesota Medical Center in Minneapolis, and Parkview Research Center in Fort Wayne."

Answered by AI
~1524 spots leftby Apr 2026