Influence of FFR on the Clinical Outcome After Percutaneous Coronary Intervention (PERSPECTIVE)

Inje University

Status: Completed

Conditions: Coronary Disease

Study type: Observational

Funder types: Other

Identifiers

NCT01873560

IB-2-1306-020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,250 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,250 participants in 1 patient group

FFRpost

Description:

High FFRpost group and low FFRpost group were defined according to the optimal cut-off value for predicting clinical outcome.