Ignite Creation Date:
2024-05-06 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03424941
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-01
First Post:
2018-01-09
Brief Title:
The TransCatheter Valve and Vessels Trial
Sponsor:
Maatschap Cardiologie Zwolle
Organization:
Maatschap Cardiologie Zwolle
Study Overview
Official Title:
TransCatheter Aortic Valve Implantation and Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Versus Conventional Surgical Aortic Valve Replacement and Coronary By-Pass Grafts for Treatment of Patients With Coronary MultiVessel Disease and Aortic Valve Stenosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
TCW
Brief Summary:
The trial objective is to investigate whether Fractional Flow Reserve FFR-Guided Percutaneous Coronary Intervention PCI and TransCatheter Aortic Valve Implantation TAVI strategy for treatment of multivessel disease and aortic stenosis will be non-inferior to Coronary Artery By-pass Grafting CABG and Surgical Aortic Valve Replacement SAVR for a composite primary endpoint of all-cause mortality stroke myocardial infarction coronary or valve re-intervention and life-threatening or disabling bleeding at one year
Detailed Description:
Prospective randomized controlled open label multicenter international non-inferiority trial
If the Heart Team decides that a coronary revascularization and aortic valve replacement is needed and the patient complies with inclusion and exclusion criteria then the patient will be randomized in a 11 fashion between FFR-guided PCI TAVI and CABG SAVR
Patients will receive optimal medical treatment at discharge Follow-up will be performed at 30 days and at one year During the 30 day follow-up visit after TAVI patients will be evaluated for symptoms of angina
If the Heart Team decides that a coronary revascularization and aortic valve replacement is needed and the patient complies with inclusion and exclusion criteria then the patient will be randomized in a 11 fashion between FFR-guided PCI TAVI and CABG SAVR
Patients will receive optimal medical treatment at discharge Follow-up will be performed at 30 days and at one year During the 30 day follow-up visit after TAVI patients will be evaluated for symptoms of angina
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?:
False
Is an FDA AA801 Violation?:
None