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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
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
Coronary artery disease defined as at least 1 coronary artery lesion of ≥70% visual angiographic diameter stenosis in a native segment that is at least 2.5 mm in diameter that is not a CTO and is amenable to treatment with percutaneous coronary intervention (PCI)
Must not have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up median follow-up of 3.5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had or will have a PCI procedure close to my TAVR surgery date.
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I am scheduled for a procedure to open blocked arteries in my heart.
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I do not have unstable blood pressure or breathing problems.
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My heart's arteries start unusually high, increasing my risk of blockage.
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My heart's left ventricle is functioning poorly.
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I am scheduled for surgery to improve blood flow to my heart.
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I have had heart bypass or valve replacement surgery.
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My kidney function is very low or I am on dialysis.
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I have not had a heart attack in the last 90 days.
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I have a health condition that is not heart-related and is expected to shorten my life to under 5 years.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
All-cause Mortality
Angina status
Bleeding
+10 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,466 Previous Clinical Trials
2,481,456 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: Medical Therapy Alone, Complete Revascularization
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
~1016 spots leftby Apr 2026
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