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Clinical Trial Summary

The primary objective of this study is to compare, in patients with severe aortic stenosis and concomitant coronary artery disease accepted for transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) by the multidisciplinary Heart Team, the safety and efficacy of instantaneous wave-free ratio (iwFR)-guided complete revascularization performed after (within 1-45 days) with iwFR-guided complete revascularization performed before (within 1-45 days) TAVI using the Edwards SAPIEN Transcatheter Heart Valve®.


Clinical Trial Description

The prevalence of coronary artery disease in patients with severe aortic stenosis is high. About 30-60% of patients undergoing TAVI exhibit coexisting coronary artery disease. Optimal timing of coronary revascularization in patients with severe aortic stenosis and concomitant coronary artery disease undergoing TAVI is uncertain. The goal of this investigator-initiated, randomized, multicenter, two-arm, open-label, non-inferiority trial is to compare two treatment strategies that are currently performed in clinical practice: PCI before TAVI versus PCI after TAVI in patients with severe aortic stenosis and concomitant coronary artery disease. In this trial, consecutive patients with severe aortic stenosis and concomitant coronary artery disease accepted for TAVI and PCI by the Heart Team will be randomized in a 1:1 ratio to the following strategies: iwFR-guided complete coronary revascularization before (within 1-45 days) or after (within 1-45 days) TAVI using the Edwards SAPIEN Transcatheter Heart Valve®. For both treatment groups, suitable lesions with iwFR≤0.89 or >90% diameter stenosis on coronary angiography in a coronary artery ≥2.5 mm in diameter are considered significant. TAVI and PCI will be performed according to current guidelines. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04310046
Study type Interventional
Source University of Zurich
Contact Barbara E. Stähli, MD, eMBA
Phone +41 44 255 11 11
Email [email protected]
Status Recruiting
Phase N/A
Start date September 30, 2020
Completion date July 2028

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