Physio PCI: Impact of Coronary Angioplasty on Non-hyperaemic Pressure Ratio in Patients With Coronary Artery Disease
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT04679805
- Lead Sponsor
- Ceric Sàrl
- Brief 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..
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
- Patient is ≥ 21 years
- The patient is deemed eligible for PCI of at least one coronary stenosis (RFRpre ≤0.89 or FFR≤0.80)
- The patient is able and is willing to comply with all study procedures and process.
- The patient is in cardiogenic shock
- The patient has a bifurcation lesion that requires a planned two stents technique
- The patient refuses to participate.
- The patient suffers acute coronary syndrome and should be treated by PCI in the culprit lesion (non-culprit lesions in non-culprit vessel could be included)
- The patient has an ostial stenosis to be treated by PCI
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method RFRpre vs. RFRfinal Intra operative, up to 1 month comparison between RFR (Resting Full Cycle Ratio) before and after optimized PCI (RFRpre vs. RFRfinal) in all included lesions
- Secondary Outcome Measures
Name Time Method FFRpre vs. FFRfinal Intra operative, up to 1 month Comparison of FFR (Fractional Flow reserve) value before and after PCI
RFRpre vs. FFRpre: % of lesions Intra operative, up to 1 month Comparison of FFR (Fractional Flow reserve) and RFR (Resting Full Cycle Ratio) value before PCI: % of lesions with FFR≤0.80 compared to RFR≤0.89.
The rate of Major Adverse Coronary Events Day 1 and Day 30 Major Adverse Coronary Events: cardiovascular mortality, myocardial infarction, ischemia driven target lesion revascularization
RFRpre vs. RFRpost Intra operative, up to 1 month Comparison of RFR (Resting Full Cycle Ratio) value before and after PCI
RFRpost vs. RFRfinal Intra operative, up to 1 month Comparison of RFR (Resting Full Cycle Ratio) value before and after PCI optimization
FFRpre vs. FFRpost Intra operative, up to 1 month Comparison of FFR (Fractional Flow reserve) value before and after PCI
FFRpost vs. FFRfinal Intra operative, up to 1 month Comparison of FFR (Fractional Flow reserve) value before and after optimized PCI
RFRpost vs. FFRpost/ % of lesions Intra operative, up to 1 month Comparison of FFR (Fractional Flow reserve) and RFR (Resting Full Cycle Ratio) value after PCI : % of lesions with FFR≤0.80 compared to RFR≤0.89
RFRfinal vs. FFRfinal/ % of lesions Intra operative, up to 1 month Comparison of FFR (Fractional Flow reserve) and RFR (Resting Full Cycle Ratio) value after optimized PCI : % of lesions with FFR≤0.80 compared to RFR≤0.89.
The rate of all cause mortality Day 1 and Day 30 All-cause mortality
Contrastpost vs. Contrastfinal. Intra operative, up to 1 month Volume of contrast dye load (cc) during the procedure after PCI and after optimization
% of patients: RFRpost vs. RFRfinal Intra operative, up to 1 month % of patients with (Resting Full Cycle Ratio) RFR \> 0.70, 0.80, 0.89 and 0.95 (in the treated vessel in case of 1 multivessel CAD) before and after optimization
The rate of Stent Thrombosis Day 1 and Day 30 Stent thrombosis according to the definition of ARC2 (definite or probable)
Proc Timepost vs. Proc Timefinal. Intra operative, up to 1 month Duration of the procedure (mn) after PCI optimization
Irradiationpost vs. Irradiationfinal. Intra operative, up to 1 month Irradiation during the procedure in mGy after PCI and after optimization:
Trial Locations
- Locations (1)
Al Qassimi Hospital
🇦🇪Sharjah, United Arab Emirates