NCT00694005

Choice Of Optimal Strategy For Bifurcation Lesions With Normal Side Branch

Phase IV Study of the Choice of Optimal Strategy for Bifurcation Lesions With Normal Side Branch

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 504 (actual)
• Sponsor: Seung-Jung Park · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Few data are available about the late patency of side branches in association with the currently used stent types and implantation techniques.

Detailed description

Among the bifurcation type, bifurcation lesion without significant side branch stenosis (\<50%) usually did not require side branch stenting, but owing to several putative mechanism including dissection, thrombosis formation, embolization of plaque debris, ostial compromise by displaced stent strut, and snow plow effect, the side branch might be compromised. In this situation, the strategy to achieve optimal results has not been reported. Recently, FFR study showed that most jailed side branch (vessel size \>2.0 mm. DS\>50%) after main branch stenting did not have functional significance. We compared strategies with or without routine kissing balloon dilatation for less than 50% stenosis after simple DES crossing for bifurcation lesions (bifurcation type 1.1.0, 1.0.0, and 0.1.0 according to Medina classification) with serial change of FFR measurement.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	kissing balloon	simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions
PROCEDURE	without kissing balloon angioplasty "leave alone"	simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions

Timeline

• Start date: 2008-01-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2008-06-09
• Last updated: 2015-11-20

Locations

11 sites across 1 country: South Korea