Few data are available about the late patency of side branches in association with the currently used stent types and implantation techniques.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
504
simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions
simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea
Busan Saint Mary's Hospital
Busan, South Korea
Cheongju Saint Mary's Hospital
Cheongju-si, South Korea
Diameter stenosis at 8-month follow-up between the kissing balloon inflation and leave alone strategy
8 month after PCI
Time frame: 8 months
Incidence of side branch jail after main vessel stenting according to the stent type used
Day 1 (24 hours after the index procedure)
Time frame: Day 1
Angiographic reocclusion rate of side branch
8month after PCI
Time frame: 8 months
Angiographic restenosis rate of side branch and the main vessel
8month after PCI
Time frame: 8 months
Late loss of side branch and the main vessel between angiography- and FFR-guided side branch procedure
8month after PCI
Time frame: 8 months
Angiographic reocclusion, restenosis rate and late loss of the side branch according to the DES type
8month after PCI
Time frame: 8 months
Angiographic reocclusion, restenosis rate and late loss of the side branch according to bifurcation angle and bifurcation type
8month after PCI
Time frame: 8 months
Composite of major cardiac adverse events (MACE) including death, MI, stent thrombosis and target vessel revascularization
Time frame: 2 years
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Chungnam National University Hospital
Daejeon, South Korea
Kyungsang University Hospital
Jinju, South Korea
Hallym University Sacred Heart Hospital
Pyeongchon, South Korea
Catholic University, Kangnam St. Mary's Hospital
Seoul, South Korea
Hallym University Sacred Heart Hospital
Seoul, South Korea
Aju University Hospital
Suwon, South Korea
Ulsan University Hospital
Ulsan, South Korea
...and 1 more locations
FFR of the side branch at post-procedure and at follow-up
Day 1 (immediately after the index procedure)and 8month after PCI
Time frame: Day 1, 8 months
Incidence of peri-procedural cardiac enzyme elevation
Day 1 (24 hours after the index procedure)
Time frame: Day 1
Fluoroscopic time
Day 1 (immediately after the index procedure)
Time frame: Day 1
Procedure time
Day 1 (immediately after the index procedure)
Time frame: Day 1
Amount of contrast agent
Day 1 (immediately after the index procedure)
Time frame: Day 1
Number of used stents
Day 1 (immediately after the index procedure)
Time frame: Day 1