NCT01621438

Clinical Implication of 3-vessel Fractional Flow Reserve (FFR)

Influence of Total Atherosclerotic Burden Assessed by 3-vessel Fractional Flow Reserve (FFR) on the Clinical Outcomes of the Patients With Multi-vessel Disease

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,136 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study will evaluate the influence of total atherosclerotic burden assessed by 3-vessel fractional flow reserve (FFR) on the clinical outcomes of the patients with multi-vessel disease. For this purpose, the clinical data of the patients with 3-vessel intermediate coronary artery disease, whose FFR was measured at all 3-vessels due to their own clinical needs, will be analyzed.

Detailed description

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

Conditions

• Multivessel Coronary Artery Disease

Timeline

• Start date: 2012-05-01
• Primary completion: 2015-03-01
• Completion: 2018-09-01
• First posted: 2012-06-18
• Last updated: 2017-08-25

Locations

20 sites across 5 countries: China, Japan, Singapore, South Korea, Taiwan