Clinical Trials Logo

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.

Clinical Trial 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,, 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03360591
Study type Interventional
Source Universita di Verona
Contact Flavio L Ribichini, MD
Phone +39 045 812
Status Recruiting
Phase N/A
Start date November 24, 2017
Completion date December 31, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT03471234 - Latin America Real World Study With Inspiron Drug Eluting Stent - INSPIRON LATITUDE
Completed NCT02115308 - Characterization of Changes in Ventricular Mechanics in Response to Lexiscan Stress Using Tagged Cine Cardiac Magnetic Resonance Imaging Phase 4
Terminated NCT01374555 - Evaluation of the CardioSond Electronic Stethoscope in the Detection of Coronary Artery Disease
Recruiting NCT03216720 - Miniaturized Extracorporeal Circulation Study N/A
Completed NCT03226262 - FFRangio Accuracy vs. Standard FFR
Recruiting NCT03378934 - Anti-platelet Effect of Berberine in Patients After Elective Percutaneous Coronary Intervention Phase 4
Recruiting NCT03707626 - Collateral Circulation to LAD and Wellens Sign
Recruiting NCT03622671 - Fibrin Clot Properties and Blood Loss Following Coronary Artery By-pass Grafting N/A
Completed NCT01930214 - Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE) N/A
Recruiting NCT03709836 - Computed Tomography Angiography Prediction Score for Side Branch Occlusion
Recruiting NCT03198806 - Water Intake Associated With Aerobic Exercise in Coronary N/A
Completed NCT02272582 - A Study to Evaluate the Use of SOMVC001 (GALA) Vascular Conduit Preservation Solution in Patients Undergoing CABG (STEPS) N/A
Recruiting NCT03265535 - Validation of a Single Rest-Stress Imaging Protocol for Myocardial Perfusion Imaging N/A
Not yet recruiting NCT03265041 - Long Term Predictors of Graft Patency After Coronary Artery Bypass Graft Surgery (Multi-slice CT Coronary Angiography Study Validated by Coronary Angiography)
Not yet recruiting NCT03646019 - Serum Oxidative Status as a Potential Predictor of Coronary Artery Disease.
Not yet recruiting NCT03620539 - Sauna Bathing to Improve Vascular Health of Adults With Heart Disease N/A
Recruiting NCT02922088 - EU Multicenter Registry to Assess Outcomes in CABG Patients: Treatment of Vascular Conduits With DuraGraft [VASC] N/A
Recruiting NCT02832115 - Topical Nitroglycerine Treatment for Radial Artery Spasm Prevention Phase 4
Recruiting NCT03518437 - Coronary Atherosclerosis Disease Early Identification and Risk Stratification by Noninvasive Imaging
Recruiting NCT02939729 - Physiotherapy Prehabilitation in Patients Undergoing Cardiac or Thoracic Surgery N/A