Ignite Creation Date:
2024-05-06 @ 3:27 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04634240
Status:
RECRUITING
Last Update Posted:
2023-12-14
First Post:
2020-11-16
Brief Title:
Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMPLETE TAVR
Brief 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 25 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 revascularization of coronary artery lesions
All patients regardless of randomized treatment allocation will receive guideline-directed medical therapy consisting of risk factor modification and use of evidence-based therapies The COMPLETE TAVR study will help address the current lack of evidence in this area It will likely impact both the global delivery of health care and the management and clinical outcomes of all patients undergoing TAVR with concomitant CAD
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 25 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 revascularization of coronary artery lesions
All patients regardless of randomized treatment allocation will receive guideline-directed medical therapy consisting of risk factor modification and use of evidence-based therapies The COMPLETE TAVR study will help address the current lack of evidence in this area It will likely impact both the global delivery of health care and the management and clinical outcomes of all patients undergoing TAVR with concomitant CAD
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None