Influence of FFR on the Clinical Outcome After Percutaneous Coronary Intervention

Coronary Disease Clinical Trial

— PERSPECTIVE  

Official title:

Influence of Fractional Flow Reserve (FFR) on the Clinical OutcomEs of PERcutaneouS Coronary Intervention (PCI): A ProspECTIVE, Multicenter FFR Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873560
• Other study ID #: IB-2-1306-020
• Status: Completed
• Start date: May 2013
• Est. completion date: December 2016

Study information

• Verified date: September 2023
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Fractional flow reserve (FFR) is a physiologic index for the determination of ischemia-causing coronary stenosis as well as drug eluting stent (DES) optimization, even multiple anatomic imaging parameters have been widely used in clinical practice for the assessment of optimal stent procedure. Prognostic value of post-stent FFR (FFRpost) have been rarely evaluated in patient treated with 2nd generation DES. This multicentre, prospective registry was aimed to evaluate the influence of physiologic parameters on the clinical outcome after 2nd generation DES implantation.

Description:

Patients who diagnosed obstructive coronary artery disease and treated by DES with FFR examination would be enrolled, consecutively. FFR measurement would be required at the baseline and at the end of index PCI procedure. PCI procedure would be performed upon local routine. Any available 2nd generation DES could be used. Informed consent should be obtained and protocol should be approved by each collaborator's institutional review board (IRB). Web-based electronic-case record form (CRF) system will be used for collecting data. All data will be handled and analyzed by blind fashion at independent core lab. Patient will be followed-up at each collaborator's hospital at least 2 year after index procedure. Any adverse event will be reported and addressed immediately by appropriate medical treatment to protect patient.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1250
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• any patient meets eligible criteria who underwent PCI with DES followed by FFR measurement at the index procedure

• patient who provide informed consent

Exclusion Criteria:

• culprit vessel of acute coronary syndrome

• failed achieving TIMI 3 flow at the end of PCI

• left ventricular ejection fraction <30%

• graft vessel

• collateral feeder

• in-stent stenosis

• primary myocardial or valvular heart disease

• in patient whose life expectancy less than 2 years

• visible thrombus of target vessel segment

Related Conditions & MeSH terms

• Coronary Disease

Locations

Country	Name	City	State
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Inje University Ilsan Paik Hospital	Goyang	Gyeonggi
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (10)

Lead Sponsor	Collaborator
Inje University	Busan Veterans General Hospital, Gifu Heart Center, Japanese Red Cross Kyoto Daini Hospital, Keimyung University Dongsan Medical Center, Samsung Medical Center, Sejong General Hospital, Seoul National University Hospital, Tokyo Medical University, Ulsan University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

Nam CW, Hur SH, Cho YK, Park HS, Yoon HJ, Kim H, Chung IS, Kim YN, Kim KB, Doh JH, Koo BK, Tahk SJ, Fearon WF. Relation of fractional flow reserve after drug-eluting stent implantation to one-year outcomes. Am J Cardiol. 2011 Jun 15;107(12):1763-7. doi: 10.1016/j.amjcard.2011.02.329. Epub 2011 Apr 8. — 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 at follow-up: a multicenter registry. Circulation. 2002 Jun 25;105(25):2950-4. doi: 10.1161/01.cir.0000020547.92091.76. — View Citation

Samady H, McDaniel M, Veledar E, De Bruyne B, Pijls NH, Fearon WF, Vaccarino V. Baseline fractional flow reserve and stent diameter predict optimal post-stent fractional flow reserve and major adverse cardiac events after bare-metal stent deployment. JACC Cardiovasc Interv. 2009 Apr;2(4):357-63. doi: 10.1016/j.jcin.2009.01.008. — View Citation

Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intravascular ultrasound (IVUS) derived predictors for post-stent FFR and target vessel failure	In patient who performed IVUS examination, IVUS derived parameters will be evaluated for the prediction of post-stent FFR and target-vessel failure	2 years after index procedure
Primary	Target-vessel failure	During two-year follow-up period, target-vessel failure (composite of cardiac death, target-vessel related myocardial infarction, and clinically-driven target vessel revascularization) will be evaluated. Target vessel will be defined as the treated vessel with DES which assessed by post-stent FFR.; All clinical outcome will be reported according to the location of target vessel (LAD vs. non-LAD).	2 years after index procedure
Secondary	clinical, angiographic and physiologic predictors for target-vessel failure	Clinical, angiographic and physiologic predictors for target-vessel failure by univariate and multivariate analysis will be performed.	2 years after index procedure