Clinical Implication of 3-vessel Fractional Flow Reserve (FFR)
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|ClinicalTrials.gov Identifier: NCT01621438|
Recruitment Status : Unknown
Verified August 2017 by Bon-Kwon Koo, Seoul National University Hospital.
Recruitment status was: Active, not recruiting
First Posted : June 18, 2012
Last Update Posted : August 25, 2017
|Condition or disease|
|Multivessel Coronary Artery Disease|
Primary Analysis The Primary Analysis will be performed after 2-year follow-up data will be completed.
Pre-specified Subgroup Analysis
The pre-specified subgroup analysis will perform after 1-year follow-up data will be completed according to the following subjects:
Concordant and discordant results between FFR and angiographic stenosis severity (patients and lesions with pre-PCI FFR will be analyzed.).
Association between total atherosclerotic burden and total ischemic burden, coronary CT angiography substudy (after 2-year follow-up will be completed).
Validation of total ischemic burden (sum of 3 vessel FFR) with Duke score, measured by treadmill test.
Comparison of clinical outcomes of deferred lesions according to pre-PCI FFR levels (Pre-PCI FFR <0.75, 0.75-0.80, and >0.80).
- Comparison of clinical outcomes of deferred lesions according to iFR and FFR values ⑥ Prognosis of functional complete revascularization versus incomplete revascularization
|Study Type :||Observational|
|Estimated Enrollment :||1136 participants|
|Official Title:||Influence of Total Atherosclerotic Burden Assessed by 3-vessel Fractional Flow Reserve (FFR) on the Clinical Outcomes of the Patients With Multi-vessel Disease|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||March 2015|
|Estimated Study Completion Date :||September 2018|
- The rate of the composite of major adverse cardiac events (MACE: cardiac death, myocardial infarction, revascularization) at 2 years per 3-vessel FFR [ Time Frame: 2 years after FFR measurement ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621438
|Principal Investigator:||Bon-Kwon Koo, MD||Cardiovascular Center, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 110-744, South Korea|