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Outcome of FFR-guided Intervention Strategy

This study is currently recruiting participants.
Verified November 2011 by Seoul National University Hospital
Sponsor:
Collaborators:
Ajou University
Keimyung University Dongsan Medical Center
Inje University
Information provided by (Responsible Party):
Bon-Kwon Koo, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01409577
First received: August 2, 2011
Last updated: November 19, 2011
Last verified: November 2011
History of Changes
  Purpose

The investigator will evaluate the clinical outcomes of the patients in whom the treatment strategy for their coronary stenosis were determined by fractional flow reserve measurement.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Outcome of Fractional Flow Reserve-guided Coronary Intervention Strategy in Koreans

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Long-term MACE [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Cardiac death, MI, target vessel revascularization, target lesion revascularization


Secondary Outcome Measures:
  • Short-term MACE [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Cardiac death, MI, TLR/TVR


Estimated Enrollment: 1500
Study Start Date: March 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
FFR
Patients with intermediate coronary stenosis Patients with successful fractional flow measurement Feasible > 9months clinical follow-up

Detailed Description:

Inclusion criteria

  • Coronary stenosis
  • Successful measurement of fractional flow reserve

Clinical outcomes

  • Death
  • Cardiac death
  • Target lesion revascularization
  • Target vessel revascularization
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with intermediate coronary stenosis by visual estimation

Criteria

Inclusion Criteria:

  • Coronary stenosis
  • Successful fractional flow reserve measurement

Exclusion Criteria:

  • Contraindication to adenosine
  • Expected life expectance < 1year
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409577

Contacts
Contact: Bon-Kwon Koo, MD, PhD 82-2-2072-2062 bkkoo@snu.ac.kr

Locations
Korea, Republic of
Ilsan Paik hospital Recruiting
Ilsan, Korea, Republic of
Contact: Joon-Hyung Do, MD, Phd            
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Bon-Kwon Koo, MD, PhD            
Sponsors and Collaborators
Seoul National University Hospital
Ajou University
Keimyung University Dongsan Medical Center
Inje University
Investigators
Principal Investigator: Bon-Kwon Koo, MD, PhD Seoul National University
  More Information

No publications provided

Responsible Party: Bon-Kwon Koo, Associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01409577     History of Changes
Other Study ID Numbers: H1102-032-350
Study First Received: August 2, 2011
Last Updated: November 19, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Hospital:
Coronary stenosis
stent
fractional flow reserve

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

ClinicalTrials.gov processed this record on June 17, 2013