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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04679805
• Other study ID #: Physio PCI Study
• Status: Terminated
• Start date: June 6, 2021
• Est. completion date: July 1, 2021

Study information

• Verified date: March 2023
• Source: Ceric Sàrl
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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..

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
United Arab Emirates	Al Qassimi Hospital	Sharjah

Sponsors (1)

Lead Sponsor	Collaborator
Ceric Sàrl

Country where clinical trial is conducted

United Arab Emirates, 

References & Publications (18)

Agarwal SK, Kasula S, Hacioglu Y, Ahmed Z, Uretsky BF, Hakeem A. Utilizing Post-Intervention Fractional Flow Reserve to Optimize Acute Results and the Relationship to Long-Term Outcomes. JACC Cardiovasc Interv. 2016 May 23;9(10):1022-31. doi: 10.1016/j.jc — View Citation

Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardize — View Citation

Davies JE, Sen S, Dehbi HM, Al-Lamee R, Petraco R, Nijjer SS, Bhindi R, Lehman SJ, Walters D, Sapontis J, Janssens L, Vrints CJ, Khashaba A, Laine M, Van Belle E, Krackhardt F, Bojara W, Going O, Harle T, Indolfi C, Niccoli G, Ribichini F, Tanaka N, Yokoi — View Citation

Doh JH, Nam CW, Koo BK, Lee SY, Choi H, Namgung J, Kwon SU, Kwak JJ, Kim HY, Choi WH, Lee WR. Clinical Relevance of Poststent Fractional Flow Reserve After Drug-Eluting Stent Implantation. J Invasive Cardiol. 2015 Aug;27(8):346-51. — View Citation

Fearon WF, Luna J, Samady H, Powers ER, Feldman T, Dib N, Tuzcu EM, Cleman MW, Chou TM, Cohen DJ, Ragosta M, Takagi A, Jeremias A, Fitzgerald PJ, Yeung AC, Kern MJ, Yock PG. Fractional flow reserve compared with intravascular ultrasound guidance for optim — View Citation

Gotberg M, Christiansen EH, Gudmundsdottir IJ, Sandhall L, Danielewicz M, Jakobsen L, Olsson SE, Ohagen P, Olsson H, Omerovic E, Calais F, Lindroos P, Maeng M, Todt T, Venetsanos D, James SK, Karegren A, Nilsson M, Carlsson J, Hauer D, Jensen J, Karlsson — View Citation

Hwang D, Lee JM, Lee HJ, Kim SH, Nam CW, Hahn JY, Shin ES, Matsuo A, Tanaka N, Matsuo H, Lee SY, Doh JH, Koo BK. Influence of target vessel on prognostic relevance of fractional flow reserve after coronary stenting. EuroIntervention. 2019 Aug 29;15(5):457 — View Citation

Kobayashi Y, Johnson NP, Berry C, De Bruyne B, Gould KL, Jeremias A, Oldroyd KG, Pijls NHJ, Fearon WF; CONTRAST Study Investigators. The Influence of Lesion Location on the Diagnostic Accuracy of Adenosine-Free Coronary Pressure Wire Measurements. JACC Ca — View Citation

Lee JM, Choi KH, Park J, Hwang D, Rhee TM, Kim J, Park J, Kim HY, Jung HW, Cho YK, Yoon HJ, Song YB, Hahn JY, Nam CW, Shin ES, Doh JH, Hur SH, Koo BK. Physiological and Clinical Assessment of Resting Physiological Indexes. Circulation. 2019 Feb 12;139(7): — View Citation

Li SJ, Ge Z, Kan J, Zhang JJ, Ye F, Kwan TW, Santoso T, Yang S, Sheiban I, Qian XS, Tian NL, Rab TS, Tao L, Chen SL. Cutoff Value and Long-Term Prediction of Clinical Events by FFR Measured Immediately After Implantation of a Drug-Eluting Stent in Patient — View Citation

Mallidi J, Atreya AR, Cook J, Garb J, Jeremias A, Klein LW, Lotfi A. Long-term outcomes following fractional flow reserve-guided treatment of angiographically ambiguous left main coronary artery disease: A meta-analysis of prospective cohort studies. Cath — View Citation

Meneveau N, Souteyrand G, Motreff P, Caussin C, Amabile N, Ohlmann P, Morel O, Lefrancois Y, Descotes-Genon V, Silvain J, Braik N, Chopard R, Chatot M, Ecarnot F, Tauzin H, Van Belle E, Belle L, Schiele F. Optical Coherence Tomography to Optimize Results — View Citation

Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC — View Citation

Pijls NH, Klauss V, Siebert U, Powers E, Takazawa K, Fearon WF, Escaned J, Tsurumi Y, Akasaka T, Samady H, De Bruyne B; Fractional Flow Reserve (FFR) Post-Stent Registry Investigators. Coronary pressure measurement after stenting predicts adverse events a — View Citation

Shaheen M, Mokarrab M, Youssef A, Aref M, Abushouk AI, Elmaraezy A, Almasswary A. Physiological evaluation of the provisional side-branch intervention strategy for bifurcation lesions using instantaneous wave-free ratio. Indian Heart J. 2018 Dec;70 Suppl — View Citation

Svanerud J, Ahn JM, Jeremias A, van 't Veer M, Gore A, Maehara A, Crowley A, Pijls NHJ, De Bruyne B, Johnson NP, Hennigan B, Watkins S, Berry C, Oldroyd KG, Park SJ, Ali ZA. Validation of a novel non-hyperaemic index of coronary artery stenosis severity: — View Citation

Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task — View Citation

van Zandvoort LJC, Masdjedi K, Witberg K, Ligthart J, Tovar Forero MN, Diletti R, Lemmert ME, Wilschut J, de Jaegere PPT, Boersma E, Zijlstra F, Van Mieghem NM, Daemen J. Explanation of Postprocedural Fractional Flow Reserve Below 0.85. Circ Cardiovasc In — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RFRpre vs. RFRfinal	comparison between RFR (Resting Full Cycle Ratio) before and after optimized PCI (RFRpre vs. RFRfinal) in all included lesions	Intra operative, up to 1 month
Secondary	RFRpre vs. RFRpost	Comparison of RFR (Resting Full Cycle Ratio) value before and after PCI	Intra operative, up to 1 month
Secondary	RFRpost vs. RFRfinal	Comparison of RFR (Resting Full Cycle Ratio) value before and after PCI optimization	Intra operative, up to 1 month
Secondary	FFRpre vs. FFRpost	Comparison of FFR (Fractional Flow reserve) value before and after PCI	Intra operative, up to 1 month
Secondary	FFRpost vs. FFRfinal	Comparison of FFR (Fractional Flow reserve) value before and after optimized PCI	Intra operative, up to 1 month
Secondary	FFRpre vs. FFRfinal	Comparison of FFR (Fractional Flow reserve) value before and after PCI	Intra operative, up to 1 month
Secondary	RFRpre vs. FFRpre: % of lesions	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.	Intra operative, up to 1 month
Secondary	RFRpost vs. FFRpost/ % of lesions	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	Intra operative, up to 1 month
Secondary	RFRfinal vs. FFRfinal/ % of lesions	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.	Intra operative, up to 1 month
Secondary	Proc Timepost vs. Proc Timefinal.	Duration of the procedure (mn) after PCI optimization	Intra operative, up to 1 month
Secondary	Irradiationpost vs. Irradiationfinal.	Irradiation during the procedure in mGy after PCI and after optimization:	Intra operative, up to 1 month
Secondary	Contrastpost vs. Contrastfinal.	Volume of contrast dye load (cc) during the procedure after PCI and after optimization	Intra operative, up to 1 month
Secondary	% of patients: RFRpost vs. RFRfinal	% 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	Intra operative, up to 1 month
Secondary	The rate of Major Adverse Coronary Events	Major Adverse Coronary Events: cardiovascular mortality, myocardial infarction, ischemia driven target lesion revascularization	Day 1 and Day 30
Secondary	The rate of all cause mortality	All-cause mortality	Day 1 and Day 30
Secondary	The rate of Stent Thrombosis	Stent thrombosis according to the definition of ARC2 (definite or probable)	Day 1 and Day 30