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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Inje University
Sponsor:
Collaborators:
Seoul National University Hospital
Keimyung University Dongsan Medical Center
Ulsan University Hospital
Hallym University Medical Center
Kangdong Sacred Heart Hospital
Busan Veterans General Hospital
Myongji Hospital
Chungbuk National University
Hanyang University
Dong-A University Hospital
Gyeongsang National University Hospital
Information provided by (Responsible Party):
Joon Hyung Doh, Inje University
ClinicalTrials.gov Identifier:
NCT01873560
First received: June 6, 2013
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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 between post-stent FFR (FFRpost) have been rarely evaluated in patient treated with DES. This multicentre, prospective registry was aimed to evaluate influence of physiologic parameters on the clinical outcome after DES implantation.


Condition
Coronary Disease

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Influence of Fractional Flow Reserve (FFR) on the Clinical OutcomEs of PERcutaneouS Coronary Intervention (PCI): A ProspECTIVE, Multicenter FFR Registry

Further study details as provided by Inje University:

Primary Outcome Measures:
  • Target vessel related major adverse cardiovascular event rate [ Time Frame: 2 years after index procedure ] [ Designated as safety issue: No ]
    During two-year follow-up period, target vessel related major adverse cardiovascular event (composite of any cardiac death, non-fatal myocardial infarction, any target vessel related revascularization) will be evaluated. Target vessel will be defined as the treated vessel with DES which assessed by post-stent FFR


Secondary Outcome Measures:
  • clinical, angiographic and physiologic predictors for MACE [ Time Frame: 2 years after index procedure ] [ Designated as safety issue: No ]
    Clinical, angiographic and physiologic predictors for target vessel related MACE by univariate and multivariate analysis will be performed.


Other Outcome Measures:
  • Intravascular ultrasound (IVUS) derived predictors for post-stent FFR and MACE [ Time Frame: 2 years after index procedure ] [ Designated as safety issue: No ]
    In patient who performed IVUS examination, IVUS derived parameters will be evaluated for the prediction of post-stent FFR and MACE


Estimated Enrollment: 1250
Study Start Date: May 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
FFRpost

FFRpost <0.9 group the patient with FFR values less than 0.9 after DES procedure

FFRpost ≥0.9 group the patient with FFR values greater than 0.9 after DES procedure


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 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.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
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

Criteria

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 with regional wall motion abnormality
  • visible thrombus of target vessel segment
  • failed achieving TIMI 3 flow at the end of PCI
  • left ventricular ejection fraction <30%
  • primary myocardial or valvular heart disease.
  • documented evidence of vasospastic angina
  • pregnant women
  • in patient whose life expectancy less than 2 years
  • chronic renal failure s-Cr > 2.5mg/dl
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01873560

Contacts
Contact: Joon Hyung Doh, MD, PhD 82319107830 joon.doh@gmail.com

Locations
Korea, Republic of
Inje University Ilsan Paik Hospital Recruiting
Goyang, Gyeonggi, Korea, Republic of, 411-706
Contact: Joon Hyung Doh, MD, PhD    82319107830    joon.doh@gmail.com   
Principal Investigator: Joon Hyung Doh, MD, PhD         
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Chang-Wook Nam, MD, PhD       namcwcv@gmail.com   
Contact: Chang-Wook Nam, Md, PhD       namcwcv@gmail.com   
Principal Investigator: Chang-wook Nam, MD, PhD         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Bon-Kwon Koo, MDPhD       bkkoo@snu.ac.kr   
Principal Investigator: Bon-Kwon Koo, MDPhD         
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of
Contact: Eun-Seok Shin, MD, PhD       ses@uuh.ulsan.kr   
Principal Investigator: Eun-Seok Shin, MD, PhD         
Sponsors and Collaborators
Inje University
Seoul National University Hospital
Keimyung University Dongsan Medical Center
Ulsan University Hospital
Hallym University Medical Center
Kangdong Sacred Heart Hospital
Busan Veterans General Hospital
Myongji Hospital
Chungbuk National University
Hanyang University
Dong-A University Hospital
Gyeongsang National University Hospital
Investigators
Principal Investigator: Joon Hyung Doh, MD, PhD Inje Univesity Ilsan Paik Hospital
Study Director: Bon-Kwon Koo Seoul National University Hospital
  More Information

Publications:
Responsible Party: Joon Hyung Doh, Associate professor, Inje University
ClinicalTrials.gov Identifier: NCT01873560     History of Changes
Other Study ID Numbers: IB-2-1306-020
Study First Received: June 6, 2013
Last Updated: May 12, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Inje University:
fractional flow reserve
drug eluting stent
coronary atherosclerosis

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on September 16, 2014