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Clinical Trial Summary

In the setting of single stent strategy for treatment of bifurcation, we investigate to compare simple strategy as "provisional final kissing balloon technique(fKBT)" to complex one as "routine FKBT", focusing on actual myocardial ischemia assessed by scintigraphy in 7-month and to examine optimal endpoint of side branch ostium.


Clinical Trial Description

Final kissing balloon technique (FKBT) is effective and accepted technique for the treatment of bifurcation. However, in complex lesion or anatomy, much procedure-time and contrast media are needed to accomplish this technique. Recent FFR study for jailed side branch (SB) demonstrated that angiographic severe stenosis at SB ostium includes "pseudo-stenosis" and stent-deployment jailing SB without FKBT has comparable impact on clinical outcome with FKBT strategy. Considering simple technique for bifurcation, we sought to investigate to compare "provisional FKBT" with "routine FKBT", focusing on actual myocardial ischemia assessed by scintigraphy in 7 month and to examine optimal endpoint of SB ostium. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01238510
Study type Interventional
Source Saiseikai Yokohama City Eastern Hospital
Contact
Status Completed
Phase Phase 4
Start date March 2010
Completion date April 2013

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