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Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement
NCT04634240 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 4,000 participants |
| Start Date | 2020-12-19 |
| Est. Completion | 2026-04-01 |
| Phase | NA |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 4,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of British Columbia, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04634240 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04634240?
The interventions under investigation include: Percutaneous Coronary Intervention (PCI) (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04634240?
This trial is sponsored by University of British Columbia, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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