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CompletedNCT02475291Updated Jul 27, 2016

Clinical Usefulness of Fractional Flow Reserve Measurement for Significant Stenosis in Proximal Coronary Artery

An observational study in Coronary Artery Disease and Stenosis, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2016-07-27.

Sponsored by Yonsei University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
26
Ages
19 Years and older
Sex
All
01

Study summary

Fractional flow reserve (FFR) is a pressure-wire-based index that is used during coronary angiography to assess the potential of a coronary stenosis to induce myocardial ischemia. Recent ESC guidelines referred to the usefulness of FFR extensively when noninvasive stress imaging is contraindicated, non-diagnostic, or unavailable. However, FFR requires additional manipulation with maximal and stable hyperemia by intravenous adenosine. More routine use of FFR for all angiographically significant stenoses would add considerable time, cost, and complexity to each PCI procedure and might also increase the risk of catheter-related complications such as coronary dissection and perforation. Although the guideline mentioned that FFR may not be useful in very high grade lesions (angiographically >90%) which always have an FFR \<0.80, it have not been revealed yet proper criteria to predict FFR \<0.80 obtained by angiographic parameters including degree of stenosis, lesion location and vessel size. It would be valuable to find more precise criteria available by conventional angiography for discrimination of functional stenosis in way to reduce the risk of additional procedure. For the purpose, the investigators will perform FFR in the lesions with significant stenosis (>70% diameter stenosis by visual estimation) and compare the angiographic parameters and FFR values in the study.

02

Conditions studied

  • Coronary Artery Disease
  • Stenosis
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 26 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

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

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with significant lesions with more than 70% diameter stenosis at proximal part of one or more major coronary arteries, regardless of revascularization strategy.

Inclusion criteria

  • Patients ≥ 19 years old
  • Typical angina
  • Stable or unstable angina pectoris
  • At least one or more major epicardial coronary arteries with significant stenosis (>70% diameter stenosis by visual estimation on angiogram) confined to the proximal portion of left anterior descending artery, left circumflex artery, or right coronary artery
  • Reference vessel diameter of target lesion ≥3.0 mm
  • Normal LV ejection fraction (≥50%) without wall motion abnormality by echocardiography

Exclusion criteria

Exclusion Criteria:

  • Previous myocardial infarction
  • Previous coronary bypass graft surgery
  • Cardiogenic shock
  • Multiple lesions in the vessel of interest
  • Contraindication or hypersensitivity to adenosine or contrast media
  • Reduced coronary blood flow (TIMI flow grade \<3) in the vessel of interest
  • Heavy calcified (definite calcified lesions on angiogram) or extremely tortuous lesions
  • Pregnant women or women with potential childbearing
  • Inability to understand or read the informed content
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
26 participants (actual)
Patient registry
No

Groups and cohorts

  • Significant coronary lesions

    Significant lesions with more than 70% diameter stenosis at proximal major coronary arteri(es).

06

What researchers measure

Primary outcomes

  1. Agreement of diagnosis between FFR-documented ischemia and angiographically significant stenosis

    Coronary lesions with FFR \<0.80 will be defined to be related with ischemia. Because all lesions in the study will be angiographically significant stenosis with DS \>70%, agreement of diagnosis between FFR-defined ischemia and angiographically significant stenosis will be obtained by the ratio of lesions with FFR \<0.80.

    Time frame: 1day

07

Study locations

1 site
  • Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
    Seoul, 120-752, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02475291
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Jun 18, 2015
Start date
Jun 2015
Primary completion
Mar 2016
Completion
May 2016
Last update
Jul 27, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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