CClinicalTrials.gg
Status unknownNCT01409577Updated Nov 22, 2011

Outcome of FFR-guided Intervention Strategy

An observational study in Coronary Artery Disease, sponsored by Seoul National University Hospital. Status unknown at 2 sites in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-11-22.

Sponsored by Seoul National University Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2011), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Inclusion criteria

  • Coronary stenosis
  • Successful measurement of fractional flow reserve

Clinical outcomes

  • Death
  • Cardiac death
  • Target lesion revascularization
  • Target vessel revascularization
02

Conditions studied

  • Coronary Artery Disease

Keywords

  • Coronary stenosis
  • stent
  • fractional flow reserve
03

In context

Coronary Artery Disease

5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 336 across 1,946 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Contraindication to adenosine
  • Expected life expectance \< 1year
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)

Groups and cohorts

  • FFR

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

06

What researchers measure

Primary outcomes

  1. Long-term MACE

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

    Time frame: 5 years

Secondary outcomes

  1. Short-term MACE

    Cardiac death, MI, TLR/TVR

    Time frame: 9 months

07

Study locations

2 of 2 sites recruiting
  • Ilsan Paik hospital
    Ilsan, Korea, Republic of
    • Joon-Hyung Do, MD, Phd · Contact
    Recruiting
  • Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
    • Bon-Kwon Koo, MD, PhD · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01409577
Lead sponsor
Seoul National University Hospital
Collaborators
Ajou University, Keimyung University Dongsan Medical Center, Inje University
Responsible party
Bon-Kwon Koo (Associate professor, Seoul National University Hospital) — Principal investigator
First posted
Aug 4, 2011
Start date
Mar 2011
Primary completion
Dec 2011 (estimated)
Completion
Dec 2011 (estimated)
Last update
Nov 22, 2011

Study contacts

Bon-Kwon Koo, MD, PhD
Contact
bkkoo@snu.ac.kr
82-2-2072-2062
Bon-Kwon Koo, MD, PhD
principal investigator · Seoul National University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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