NCT04679805

Physio PCI: Impact of Coronary Angioplasty on Non-hyperaemic Pressure Ratio in Patients With Coronary Artery Disease

Impact of Coronary Angioplasty on Non-hyperaemic Pressure Ratio in Patients With Coronary Artery Disease.

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 3 (actual)
• Sponsor: Ceric Sàrl · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The use of intra coronary physiological assessment with fractional flow reserve (FFR) is nowadays the standard approach to define ischemia-inducing stenosis and guide myocardial revascularization strategy in patients with coronary artery disease. Further, FFR has been shown to be a strong and independent predictor of major adverse cardiac events after stent implantation. A lower value of FFR after stent implantation is associated with a worse clinical prognosis, without a clearly defined threshold above which clinical follow up are similar for all FFR values. Among 750 patients in the Fractional Flow Reserve Post-Stent Registry, the event rate was 29.5% in patients with FFR\<0.80 compared to 9 4.9% in patients with FFR\>0.95 (p\<0.001). However, FFR remains poorly adopted in many cathlabs, partly because of procedural time, discomfort or sides effect during hyperemia, non-uniform adenosine response and economical constraints. This leads to the validation of resting indices (instantaneous wave-free ratio (iFR), diastolic pressure ratio (dPR), and resting full-cycle ratio (RFR) among others). Those indices evaluate coronary physiology without the use of maximal hyperemia and have 15 slightly different threshold compared to FFR (≤0.89 vs 0.80, for iFR and RFR, and FFR 16 respectively).In the VALIDATE RFR study, a head-to-head comparison of RFR and iFR from a retrospective analysis, diagnostic accuracy of RFR was 97.4% with an area under the curve 1 (AUC) of 99.6%. In the more recent RE-VALIDATE RFR study, 431 patients with 501 lesions 2 were prospectively evaluated for the diagnostic performance of RFR in all-comers patients. Compared to iFR, RFR achieved high diagnostic accuracy, sensitivity and specificity. These are the reasons why we designed a prospective, non-randomized, clinical trial, to better 18 explore the value of RFR before and after PCI in real live and after optimization by post dilation 19 in all-comers patients with coronary artery disease in the Middle East region..

Conditions

• Coronary Artery Disease

Timeline

• Start date: 2021-06-06
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2020-12-22
• Last updated: 2023-03-13

Locations

1 site across 1 country: United Arab Emirates