Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT03360591 |
Other study ID # |
FAITAVI |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 24, 2017 |
Est. completion date |
June 2024 |
Study information
Verified date |
May 2023 |
Source |
Universita di Verona |
Contact |
Flavio L Ribichini, MD |
Phone |
+39 045 812 |
Email |
flavio.ribichini[@]univr.it |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
Nowadays there are no clear recommendations about treatment of coronary in patients with
severe aortic valve stenosis eligible for percutaneous valve replacement, and those available
rely on a "common sense", class C, level of evidence. No randomized trials debride the skein
about the best strategy of revascularization in this complex group of patients. In
particular, it remains unclear whether it is preferable a preventive treatment or an
ischemia-driven revascularization and, in addition, if it is safer and better for patient's
health a simultaneous or a staged strategy.
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.
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 %DS>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, according to recent observations 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. The study is
designed as randomized, prospective, multi.center, open label, experimental trial with
medical device. After discharge patients will be contacted at 30 days, 6 - 12 and 24 months
after the procedure to assess the general clinical status and at 12 months to assess the
occurrence of events included in the primary and secondary endpoints. The duration of study
participation is 24 months for enrolment, ad 24 months for final follow-up.