We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Outcome of FFR-guided Intervention Strategy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2011 by Bon-Kwon Koo, Seoul National University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01409577
First Posted: August 4, 2011
Last Update Posted: November 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ajou University
Keimyung University Dongsan Medical Center
Inje University
Information provided by (Responsible Party):
Bon-Kwon Koo, Seoul National University Hospital
  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

Further study details as provided by Bon-Kwon Koo, Seoul National University Hospital:

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


Secondary Outcome Measures:
  • Short-term MACE [ Time Frame: 9 months ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Criteria

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


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

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 Submitted: August 2, 2011
First Posted: August 4, 2011
Last Update Posted: November 22, 2011
Last Verified: November 2011

Keywords provided by Bon-Kwon Koo, 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