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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02475291
Enrollment
26
Registered
2015-06-18
Start date
2015-06-30
Completion date
2016-05-31
Last updated
2016-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Stenosis

Brief 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.

Interventions

None listed

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Agreement of diagnosis between FFR-documented ischemia and angiographically significant stenosis1dayCoronary 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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026