NCT01409577

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

November 22, 2011

Status Verified

November 1, 2011

Enrollment Period

9 months

First QC Date

August 2, 2011

Last Update Submit

November 19, 2011

Conditions

Coronary Artery Disease

Keywords

Coronary stenosisstentfractional flow reserve

Outcome Measures

Primary Outcomes (1)

  • Long-term MACE

    Cardiac death, MI, target vessel revascularization, target lesion revascularization

    5 years

Secondary Outcomes (1)

  • Short-term MACE

    9 months

Study Arms (1)

FFR

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with intermediate coronary stenosis by visual estimation

You may qualify if:

  • Coronary stenosis
  • Successful fractional flow reserve measurement

You may not qualify if:

  • Contraindication to adenosine
  • Expected life expectance \< 1year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ilsan Paik hospital

Ilsan, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary Stenosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Bon-Kwon Koo, MD, PhD

    Seoul National University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bon-Kwon Koo, MD, PhD

CONTACT

82-2-2072-2062bkkoo@snu.ac.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 2, 2011

First Posted

August 4, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

November 22, 2011

Record last verified: 2011-11

Locations

KR(2)