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Functional Assessment in TAVI: FAITAVI

NCT03360591 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2025-03-21

No results posted yet for this study

Summary

The aim of this study is to compare the clinical outcome of patients with severe aortic valve stenosis and associated significant coronary artery disease treated with TAVI and a percutaneous myocardial revascularization dictated according to two different strategies:

1. the Angiographically-guided strategy;
2. the Physiologically-guided strategy.

Conditions

Interventions

DEVICE

Physiologically-guided strategy

The Angiographically-guided strategy is that of aiming the most complete degree of revascularization based on angiographic evaluation (stenting all coronary stenosis of major branches \>2.5mm, with a % coronary stenosis\>50% as evaluated by visual estimation. The Physiologically-guided strategy is that of treating only lesions with FFR ≤0.80, and leaving on optimal medical treatment lesions with FFR \>0.80. The iFR values will be recorded in all patients, and verified in the core laboratory to allow a post-hoc analysis correlating the 0.80 FFR cut-off with different iFR cut-off values, and using the same study end-points. Particular attention will be dedicated to the eventual occurrence of clinical events in patients deferred on the bases of FFR values \>0.80 that show a discrepancy with positive (\<0.89) iFR values to investigate the reliability of the FFR in the aortic stenosis setting. Both groups will receive the same TAVI strategy and optimal medical therapy

Sponsors & Collaborators

  • Universita di Verona

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-24
Primary Completion
2024-06-30
Completion
2025-06-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03360591 on ClinicalTrials.gov