Influence of FFR on the Clinical Outcome After Percutaneous Coronary Intervention

Completed

• Conditions: Coronary Disease

• Registration Number: NCT01873560
• Lead Sponsor: Inje University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-06-06
• Study First Submitted QC: 2013-06-06
• Study First Posted: 2013-06-10
• Primary Completion: 2016-06
• Study Completion: 2016-12
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target-vessel failure	2 years after index procedure	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).

Secondary Outcome Measures

Name	Time	Method
clinical, angiographic and physiologic predictors for target-vessel failure	2 years after index procedure	Clinical, angiographic and physiologic predictors for target-vessel failure by univariate and multivariate analysis will be performed.

Trial Locations

Locations (4)

Inje University Ilsan Paik Hospital; 🇰🇷 Goyang, Gyeonggi, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of