Optimal Timing of Transcatheter Aortic Valve Implantation & Percutaneous

Status Recruiting

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 fractional flow reserve (FFR)-guided complete revascularization performed after (within 1-40 days) with FFR-guided complete revascularization performed before (within 1-40 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 either FFR-guided complete coronary revascularization before (within 1-40 days) or after (within 1-40 days) TAVI using the Edwards SAPIEN Transcatheter Heart Valve®. For both treatment groups, suitable lesions with FFR≤0.80 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

Clinical Trial Details

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 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial — TAVI-PCI

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms