Outcome of FFR-guided Intervention Strategy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Seoul National University Hospital.
Recruitment status was  Recruiting
Ajou University
Keimyung University Dongsan Medical Center
Inje University
Information provided by (Responsible Party):
Bon-Kwon Koo, Seoul National University Hospital
ClinicalTrials.gov Identifier:
First received: August 2, 2011
Last updated: November 19, 2011
Last verified: November 2011
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.

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

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)
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

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

Inclusion Criteria:

  • Coronary stenosis
  • Successful fractional flow reserve measurement

Exclusion Criteria:

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

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

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
Principal Investigator: Bon-Kwon Koo, MD, PhD Seoul National University
  More Information

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
fractional flow reserve

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

ClinicalTrials.gov processed this record on April 27, 2016