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NCT04634240 · ClinicalTrials.gov registry record · NA

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

A NA study of Coronary Artery Disease and Aortic Stenosis, sponsored by University of British Columbia.

Recruiting
Registry status
NA
Development phase
4,000
Enrollment target
20
Study locations

NCT04634240 is a NA study of Coronary Artery Disease and Aortic Stenosis that is actively recruiting participants, run by University of British Columbia. The registered enrollment target is 4,000 participants, above the 1,269-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (215% higher). The trial reports 20 study locations across 10 states.

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The verdict

NCT04634240, a NA study of Coronary Artery Disease and Aortic Stenosis, is actively recruiting participants, sponsored by University of British Columbia.

RECRUITING
Registry status
NA
Development phase
4,000 participants
Enrollment target
20
Study locations

Study Summary

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 revascul

Conditions Studied

Coronary Artery Disease Aortic Stenosis Coronary Stenosis

Interventions

  • PROCEDURE Percutaneous Coronary Intervention (PCI)

Study Locations (20)

California

  • Veteran Affairs Palo Alto Health Care System - Palo Alto
  • Loma Linda University - Redlands
  • Santa Barbara Cottage Hospital - Santa Barbara
  • Torrance Memorial Medical Center - Torrance

Florida

  • JFK Medical Center - Atlantis
  • Baptist Health Jacksonville - Jacksonville
  • Miami Cardiac and Vascular/Baptist Hospital - Miami

Kansas

  • University of Kansas Medical Center - Kansas City
  • Midwest Heart and Vascular - Overland Park
  • Cardiovascular Research Institute of Kansas - Wichita

Georgia

  • Piedmont - Atlanta
  • Northeast Georgia Health System - Gainesville

Indiana

  • Midwest Cardiovascular Research and Education Foundation - Elkhart
  • Parkview Research Center - Fort Wayne

Massachusetts

  • Tufts Medical - Boston
  • Massachusetts General Hospital - Boston

Alabama

  • Huntsville Heart Center - Huntsville

Arizona

  • Arizona Cardiovascular Research - Phoenix

Trial Details

FieldValue
Enrollment Target 4,000 participants
Start Date 2020-12-19
Est. Completion 2026-04-01
Phase NA

Sponsor

University of British Columbia

18 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04634240

The ClinicalTrials.gov registry entry for NCT04634240 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 4,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,269-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (215% higher). The listed sponsor is University of British Columbia, which has 18 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which Percutaneous Coronary Intervention (PCI) is the first listed.

NCT04634240 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Kansas.

Frequently Asked Questions

What is clinical trial NCT04634240 about?

NCT04634240 is a clinical study titled "Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement". 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 re...

What is the current status of trial NCT04634240?

This trial is currently recruiting. It is a NA study. The enrollment target is 4,000 participants. The study started on 2020-12-19. Estimated completion is 2026-04-01.

What conditions does trial NCT04634240 study?

This clinical trial studies the following conditions: Coronary Artery Disease, Aortic Stenosis, Coronary Stenosis.

What interventions are being tested in trial NCT04634240?

The interventions under investigation include: Percutaneous Coronary Intervention (PCI) (PROCEDURE).

Who is sponsoring clinical trial NCT04634240?

This trial is sponsored by University of British Columbia, which has 18 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04634240 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.