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Outcome of FFR-guided Intervention Strategy

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ClinicalTrials.gov Identifier: NCT01409577
Recruitment Status : Unknown
Verified November 2011 by Bon-Kwon Koo, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : August 4, 2011
Last Update Posted : November 22, 2011
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Coronary Artery Disease

Detailed Description:

Inclusion criteria

  • Coronary stenosis
  • Successful measurement of fractional flow reserve

Clinical outcomes

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

Study Design

Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Outcome of Fractional Flow Reserve-guided Coronary Intervention Strategy in Koreans
Study Start Date : March 2011
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011
Groups and Cohorts

Patients with intermediate coronary stenosis Patients with successful fractional flow measurement Feasible > 9months clinical follow-up

Outcome Measures

Primary Outcome Measures :
  1. Long-term MACE [ Time Frame: 5 years ]
    Cardiac death, MI, target vessel revascularization, target lesion revascularization

Secondary Outcome Measures :
  1. Short-term MACE [ Time Frame: 9 months ]
    Cardiac death, MI, TLR/TVR

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: August 4, 2011    Key Record Dates
Last Update Posted: November 22, 2011
Last Verified: November 2011

Keywords provided by Bon-Kwon Koo, Seoul National University Hospital:
Coronary stenosis
fractional flow reserve

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