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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Constriction, Pathologic Coronary Disease Heart Diseases Myocardial Ischemia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Stenosis Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Time frame: 1day

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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Jun 18, 2015
Registry last updated: Jul 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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