Modified T-Stenting With Szabo Technique Versus T-Stenting for Bifurcation Lesions in Coronary Heart Diseases: SZABO Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Composite of cardiac death, nonfatal myocardial infarction and target lesion revascularization
研究概览
简要总结
The study will compare clinical outcomes of modified T-stenting with Szabo technique with T-stenting for bifurcation lesions in coronary heart diseases.
详细描述
Accurate deployment of stents in ostial lesions is difficult with traditional angiographic guidance. Szabo technique, which used a second angioplasty guide wire to anchor the stent by passing the proximal end of the anchor wire through the last cell of the stent, demonstrated accurate placement of the stents in ostial locations. In bifurcation lesions, 2-stent strategy positioning with Szabo technique was not investigated. Modified T-stenting with Szabo technique may improve prognosis of bifurcation lesions through reducing stents overlap. There is no clinical trial focuses on the effect and outcome of Szabo technique for coronary artery bifurcation lesions in contrast with conventional strategy.
In this study, the authors choose the closest 2-stent strategy, T-stenting, as control. We hope to determine whether a planned Szabo 2-stent technique is superior to T-stenting for patients with bifurcation lesions.
Patients with bifurcation lesions will be randomly assigned to receive Szabo 2-stent technique or T-stenting strategy. Clinical outcomes and imaging assessment will be used to estimate their effects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be at least ≥18 years of age.
- •Lesions are eligible for percutaneous coronary intervention (PCI).
- •Patient has stable/unstable angina or myocardial infarction (MI).
- •Bifurcation lesions (Medina 1,1,1/0,1,1/1,0,1) without left main ostial lesions.
- •Downstream lesions could be covered by two stents.
- •Diameter of vessel ≥2.25mm
- •Diameter stenosis in main vessel and side branch ≥ 50% by visual estimation.
排除标准
- •Severe tortuosity or calcification affected procedural success.
- •Patient was allergic to the study stent or protocol-required concomitant medications.
- •Patient is intolerable to dual anti-platelet therapy.
- •Patient has any other serious medical illness that may reduce life expectancy to<12 months.
- •Patient is a woman who is pregnant or nursing.
- •Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation.
- •Patient is participating in another clinical trial that has not reached its primary endpoint within 24 months after the index procedure.
- •Coronary restenosis.
研究组 & 干预措施
T-Stenting Technique
Patients received 2-stents implantation guided with T-stenting technique in bifurcation lesion.
干预措施: T-Stenting Technique (Procedure)
Szabo T-Stenting Technique
Patients received 2-stents implantation guided with Szabo technique in bifurcation lesion.
干预措施: Szabo T-Stenting Technique (Procedure)
Szabo T-Stenting Technique
Patients received 2-stents implantation guided with Szabo technique in bifurcation lesion.
干预措施: T-Stenting Technique (Procedure)
T-Stenting Technique
Patients received 2-stents implantation guided with T-stenting technique in bifurcation lesion.
干预措施: Szabo T-Stenting Technique (Procedure)
结局指标
主要结局
Composite of cardiac death, nonfatal myocardial infarction and target lesion revascularization
时间窗: 1 year after coronary angiography
record in follow-up
次要结局
- rate of all cause death(30 days and 12 months after primary angiography)
- rate of cardiac death rate(30 days and 12 months after primary angiography)
- late lumen loss(index procedure and 12 months follow up)
- rate of recurrent myocardial infarction rate(30 days and 12 months after primary angiography)
- rate of stent thrombosis(30 days and 12 months after primary angiography)
- residual stenosis of side branch(Immediately after stent implantation and 12 months after primary angiography)
- rate of target vessel revascularization rate(30 days and 12 months after primary angiography)
- residual stenosis degree(Immediately after stent implantation and 12 months after primary angiography)
研究者
Junbo Ge
Professor Ge
Shanghai Zhongshan Hospital