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

September 26, 2023 updated by: Joon Hyung Doh, Inje University

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Keimyung University Dongsan Medical Center
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Ulsan, Korea, Republic of
        • Ulsan University Hospital
    • Gyeonggi
      • Goyang, Gyeonggi, Korea, Republic of, 411-706
        • Inje University Ilsan Paik Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who diagnosed obstructive coronary artery disease and treated by DES with FFR examination at the index procedure

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target-vessel failure
Time Frame: 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).
2 years after index procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical, angiographic and physiologic predictors for target-vessel failure
Time Frame: 2 years after index procedure
Clinical, angiographic and physiologic predictors for target-vessel failure by univariate and multivariate analysis will be performed.
2 years after index procedure

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intravascular ultrasound (IVUS) derived predictors for post-stent FFR and target vessel failure
Time Frame: 2 years after index procedure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inje University

Collaborators

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

Investigators

  • Principal Investigator: Joon Hyung Doh, MD, PhD, Inje Univesity Ilsan Paik Hospital
  • Study Director: Bon-Kwon Koo, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

June 6, 2013

First Submitted That Met QC Criteria

June 6, 2013

First Posted (Estimated)

June 10, 2013

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IB-2-1306-020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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