The TransCatheter Valve and Vessels Trial (TCW)
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- STATUS
- Recruiting
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- End date
- Nov 1, 2024
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- participants needed
- 328
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- sponsor
- Maatschap Cardiologie Zwolle
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.
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 1:1 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.
Details
| Condition | Aortic Stenosis, Multi Vessel Coronary Artery Disease, TAVI, CABG, PCI, Fractional Flow Reserve |
|---|---|
| Treatment | FFR-guided PCI and TAVI, CABG and SAVR |
| Clinical Study Identifier | NCT03424941 |
| Sponsor | Maatschap Cardiologie Zwolle |
| Last Modified on | 4 October 2022 |
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