Outcome of FFR-guided Intervention Strategy

November 19, 2011 updated by: Bon-Kwon Koo, Seoul National University Hospital

Clinical Outcome of Fractional Flow Reserve-guided Coronary Intervention Strategy in Koreans

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

Inclusion criteria

  • Coronary stenosis
  • Successful measurement of fractional flow reserve

Clinical outcomes

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

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Ilsan, Korea, Republic of
        • Recruiting
        • Ilsan Paik Hospital
        • Contact:
          • Joon-Hyung Do, MD, Phd
      • Seoul, Korea, Republic of, 110-744
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Bon-Kwon Koo, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with intermediate coronary stenosis by visual estimation

Description

Inclusion Criteria:

  • Coronary stenosis
  • Successful fractional flow reserve measurement

Exclusion Criteria:

  • Contraindication to adenosine
  • Expected life expectance < 1year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term MACE
Time Frame: 5 years
Cardiac death, MI, target vessel revascularization, target lesion revascularization
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-term MACE
Time Frame: 9 months
Cardiac death, MI, TLR/TVR
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Inje University
Keimyung University Dongsan Medical Center
Ajou University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

August 2, 2011

First Submitted That Met QC Criteria

August 3, 2011

First Posted (Estimate)

August 4, 2011

Study Record Updates

Last Update Posted (Estimate)

November 22, 2011

Last Update Submitted That Met QC Criteria

November 19, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H1102-032-350

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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