Clinical trial NCT04679805: Physio PCI: Impact of Coronary Angioplasty on Non-hyperaemic Pressure Ratio in Patients With Coronary Artery Disease
Official title: Impact of Coronary Angioplasty on Non-hyperaemic Pressure Ratio in Patients With Coronary Artery Disease.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronary Artery Disease
Keywords: Percutaneous Coronary Intervention
Fractional Flow Reserve
Resting Full Cycle Ratio
Lead sponsor: Ceric Sàrl
Sponsor class: INDUSTRY
First posted: 2020-12-22
Enrollment: 3
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female subjects could be enrolled in the present study if they are 21 years old or older at the time of inclusion. The trial will enroll 100 patients who need to meet ALL eligibility criteria and provide written informed consent prior to inclusion.

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..


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: RFRpre vs. RFRfinal
timeFrame: Intra operative, up to 1 month
Secondary outcomes:
measure: RFRpre vs. RFRpost
timeFrame: Intra operative, up to 1 month
measure: RFRpost vs. RFRfinal
timeFrame: Intra operative, up to 1 month
measure: FFRpre vs. FFRpost
timeFrame: Intra operative, up to 1 month
measure: FFRpost vs. FFRfinal
timeFrame: Intra operative, up to 1 month
measure: FFRpre vs. FFRfinal
timeFrame: Intra operative, up to 1 month
measure: RFRpre vs. FFRpre: % of lesions
timeFrame: Intra operative, up to 1 month
measure: RFRpost vs. FFRpost/ % of lesions
timeFrame: Intra operative, up to 1 month
measure: RFRfinal vs. FFRfinal/ % of lesions
timeFrame: Intra operative, up to 1 month
measure: Proc Timepost vs. Proc Timefinal.
timeFrame: Intra operative, up to 1 month
measure: Irradiationpost vs. Irradiationfinal.
timeFrame: Intra operative, up to 1 month
measure: Contrastpost vs. Contrastfinal.
timeFrame: Intra operative, up to 1 month
measure: % of patients: RFRpost vs. RFRfinal
timeFrame: Intra operative, up to 1 month
measure: The rate of Major Adverse Coronary Events
timeFrame: Day 1 and Day 30
measure: The rate of all cause mortality
timeFrame: Day 1 and Day 30
measure: The rate of Stent Thrombosis
timeFrame: Day 1 and Day 30
Other outcomes:
Locations:
city: Sharjah
country: United Arab Emirates
facility: Al Qassimi Hospital
Study officials:
affiliation: Al Qassimi Hospital
name: Arif Al Nooryani
role: PRINCIPAL_INVESTIGATOR
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