Fractional Flow Reserve and Intravascular Ultrasound in Evaluating Intermediate Coronary Lesions
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Purpose
Recent studies have shown that optimal IVUS criteria defining the functional significance (FFR < 0.8) of intermediate coronary stenoses is different according to their locations of the coronary tree. Herein, the investigators performed this study to validate these results and to generalize the IVUS criteria defining functional significance of intermediate coronary stenosis in a different location of coronary tree in a larger sample size.
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Retrospective |
| Official Title: | Comparison of Fractional Flow Reserve (FFR) and Minimal Luminal Area (MLA) by Intravascular Ultrasound (IVUS) in Evaluating Intermediate Coronary Artery Stenosis: International Multi-center Study |
- lumen area [ Time Frame: day 1 ] [ Designated as safety issue: No ]lumen area cut-off that can predict functional significance of a lesion
- angiographic stenosis, % plaque area [ Time Frame: day 1 ] [ Designated as safety issue: No ]angiographic and intravascular ultrasound parameters that can best predict the functional significance of lesions
| Estimated Enrollment: | 1000 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | November 2011 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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intermediate lesion
intermediate lesions evaluated by both IVUS and FFR
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Detailed Description:
Both physiologic information from fractional flow reserve (FFR) and anatomical information from intravascular ultrasound (IVUS) in assessing intermediate coronary stenotic lesions are useful. Functional significance of a coronary stenosis is determined by both the severity of a stenosis and the amount of myocardium supplied. Therefore, when the functional significance of a lesion is assessed by lumen area measured by IVUS, different criteria should be applied according to lesion location and anatomical variations of the coronary artery. However, previous studies included only patients with proximal lesions or small vessel disease, and the sample sizes were too small to assess these differences. In a recent study, the investigators have shown that optimal IVUS criteria defining the functional significance (FFR < 0.8) of intermediate coronary stenoses is different according to their locations of the coronary tree. Herein, the investigators performed this study to validate the our results and to generalize the IVUS criteria defining functional significance of intermediate coronary stenosis in a different location of coronary tree in a larger sample size.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with intermediate coronary stenosis who underwent both FFR and IVUS
Inclusion Criteria:
- Intermediate coronary stenosis by visual estimation
Exclusion Criteria:
- history of coronary artery bypass graft surgery
- previously revascularized lesion
- creatinine > 1.6 mg/dL or eGFR < 30 ml/min/1.73m2 pre-procedure per institutional standards
- known pregnancy
- contrast agent allergy that cannot be adequately premedicated
- severe PVD precluding cardiac catheterization
- patient not a candidate for IVUS and FFR
- inability or unwillingness to provide informed consent
- inability or unwillingness to perform required follow up procedures
Contacts and Locations| Contact: Bon-Kwon Koo, MD/PhD | 82-2-2072-2062 | bkkoo@snu.ac.kr |
| Korea, Republic of | |
| Seoul National University Hospital | Recruiting |
| Seoul, Korea, Republic of, 110-744 | |
| Contact: Bon-Kwon Koo, MD/PhD 82-2-2072-2062 bkkoo@snu.ac.kr | |
| Principal Investigator: Bon-Kwon Koo, MD/PhD | |
| Principal Investigator: | Bon-Kwon Koo, MD, PhD | Seoul National University |
More Information
No publications provided
| Responsible Party: | Division of cardiology / Cardiovascular center, Seoul National University Hospital |
| ClinicalTrials.gov Identifier: | NCT01414361 History of Changes |
| Other Study ID Numbers: | H-1106-077-366 |
| Study First Received: | August 9, 2011 |
| Last Updated: | August 10, 2011 |
| Health Authority: | South Korea: Institutional Review Board |
Keywords provided by Seoul National University Hospital:
|
Coronary artery stenosis Fractional flow reserve Intravascular ultrasonography |
Additional relevant MeSH terms:
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Constriction, Pathologic Coronary Stenosis Pathological Conditions, Anatomical Coronary Disease |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on June 17, 2013