Predilation of Side Branch During Percutaneous Treatment of Bifurcation Lesions With Provisional T Stenting.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 420
- 试验地点
- 2
- 主要终点
- Side branch coronary flow after main vessels stent implantation
研究概览
简要总结
Percutaneous treatment of bifurcation lesion is a complex procedure. After main vessel stent implantation, the side branch became jailed and the carina can be displaced resulting in complete occlusion of this vessel. Re-wiring the side branch in this conditions may result difficult and some times impossible. There is no agreement regarding the need of side branch pre-dilation (before main vessel stent implantation) to reduce these complications. Researchers from European Bifurcation Club have proposed no to pre-dilate the side branch to avoid vessel dissection and difficulties in rewiring the true lumen of the vessel. On the contrary, our group has a good experience in the treatment of bifurcation lesions treated with side branch pre-dilation.
Aims: 1.- To determine the efficacy of the side-branch pre-dilation in patients with bifurcations lesions treated with provisional T stenting. 2.- To determine the success rate and incidence of complications in patients with and without side-branch pre-dilation, as well as economic impact in terms of number of used wires.
详细描述
Introduction: Percutaneous treatment of bifurcation lesion is a complex procedure. After main vessel stent implantation, the side branch became jailed and the carina can be displaced resulting in complete occlusion of this vessel. Re-wiring the side branch in this conditions may result difficult and some times impossible. There is no agreement regarding the need of side branch pre-dilation (before main vessel stent implantation) to reduce these complications. Researchers from European Bifurcation Club have proposed no to pre-dilate the side branch to avoid vessel dissection and difficulties in rewiring the true lumen of the vessel. On the contrary, our group has a good experience in the treatment of bifurcation lesions treated with side branch pre-dilation.
Aims: 1.- To determine the efficacy of the side-branch pre-dilation in patients with bifurcations lesions treated with provisional T stenting. 2.- To determine the success rate and incidence of complications in patients with and without side-branch pre-dilation, as well as economic impact in terms of number of used wires.
Design: Prospective and randomized study. Patients and methods: The series is constituted by 420 patients with bifurcations lesions that will be treated with drug-eluting stents; 210 patients will be treated with side branch pre-dilation before main vessels stent implantation, while the remaining 210 patients will be randomized to no pre-dilation of the side-branch.
Primary end point:
- TIMI flow at Side Branch after main vessel stent implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with atherosclerotic coronary disease and bifurcation lesions an significant stenosis of the side branch.
- •Main vessels diameter greater than 2.5 mm in diameter at the operator's visual estimate.
- •The side branch should exceed 2.25 mm in diameter at the operator's visual estimate.
- •Patients with damage to the main branch of any length and the side branch lesions smaller than 5 mm in length.
- •Patients with bifurcation lesions fulfilling the following morphologies of the classification of Medina: 1 1 1, 1 0 1, 0 1
- •Treatment of bifurcation lesions with previsional drug eluting stents.
- •Symptoms of stable angina or acute coronary syndrome.
排除标准
- •Contraindication to drug eluting stent implantation.
- •Cardiogenic shock.
- •Coexistence of other serious systemic diseases.
- •Patients in whom it is impossible to guide placement in the side branch before stent implantation in the main vessel.
- •Patients with bifurcation lesions and side branch less than 2 mm.
研究组 & 干预措施
Pre-dilation side branch
干预措施: Pre-dilation side branch (Procedure)
No pre-dilation side branch
结局指标
主要结局
Side branch coronary flow after main vessels stent implantation
时间窗: Immediately after catheterization procedure
次要结局
- Levels of markers of myocardial injury (CK and TpI) after the procedure(Immediately after catheterization procedure)
- Related cardiac events at 9 months(Immediately after catheterization procedure)
- Time required for rewiring of the side branch(Inmediately after catheterization procedure)
- Number of used wires(Inmediately after catheterization procedure)