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Completed

NCT Number: NCT01873560

Influence of FFR on the Clinical Outcome After Percutaneous Coronary Intervention

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.

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Key information

Conditions

Coronary Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Inje University Ilsan Paik Hospital, Goyang-si, Gyeonggi-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Inje University

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: PERSPECTIVE

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 10, 2013
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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