Phase IV Study of the Choice of Optimal Strategy for Bifurcation Lesions With Normal Side Branch
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 504
- 试验地点
- 14
- 主要终点
- Diameter stenosis at 8-month follow-up between the kissing balloon inflation and leave alone strategy
研究概览
简要总结
Few data are available about the late patency of side branches in association with the currently used stent types and implantation techniques.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with angina and documented ischemia or patients with documented silent ischemia
- •Patients who are eligible for intracoronary stenting
- •Age >18 years, <75 ages
- •Angiographic
- •De novo lesion located in a major bifurcation point with the MEDINA classification type 1.1.0, 1.0.0, or 0.1.0
- •Main vessel : >= 2.5 mm in vessel size, >= 50% in diameter stenosis and =< 50 mm in lesion length by visual estimation, in which the lesion is covered with =< 2 stents
- •Side branch :>= 2.0 mm in vessel size and < 50% diameter stenosis by visual estimation
排除标准
- •History of bleeding diathesis or coagulopathy
- •Known hypersensitivity or contra-indication to contrast agent, heparin, sirolimus, paclitaxel and zotarolimus
- •Limited life-expectancy (less than 1 year) due to combined serious disease
- •ST-elevation acute myocardial infarction =< 2 weeks
- •Characteristics of lesion:
- •Left main disease
- •In-stent restenosis
- •Graft vessels
- •TIMI flow =< grade 2 in the side branch
- •Chronic total occlusion
- •Renal dysfunction, creatinine >= 2.0mg/dL
- •Contraindication to aspirin, clopidogrel or cilostazol
研究组 & 干预措施
bifurcation stent techniqe
cross over stenting without kissing balloon angioplasty "leave alone"
干预措施: without kissing balloon angioplasty "leave alone" (Procedure)
bifurcation stent technique
kissing balloon angioplasty
干预措施: kissing balloon (Procedure)
结局指标
主要结局
Diameter stenosis at 8-month follow-up between the kissing balloon inflation and leave alone strategy
时间窗: 8 months
8 month after PCI
次要结局
- Fluoroscopic time(Day 1)
- Procedure time(Day 1)
- Number of used stents(Day 1)
- Angiographic restenosis rate of side branch and the main vessel(8 months)
- Incidence of side branch jail after main vessel stenting according to the stent type used(Day 1)
- Angiographic reocclusion rate of side branch(8 months)
- FFR of the side branch at post-procedure and at follow-up(Day 1, 8 months)
- Late loss of side branch and the main vessel between angiography- and FFR-guided side branch procedure(8 months)
- Angiographic reocclusion, restenosis rate and late loss of the side branch according to bifurcation angle and bifurcation type(8 months)
- Composite of major cardiac adverse events (MACE) including death, MI, stent thrombosis and target vessel revascularization(2 years)
- Angiographic reocclusion, restenosis rate and late loss of the side branch according to the DES type(8 months)
- Incidence of peri-procedural cardiac enzyme elevation(Day 1)
- Amount of contrast agent(Day 1)
研究者
Seung-Jung Park
MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine
CardioVascular Research Foundation, Korea