Jailed Wire Technique in the Treatment of Coronary Bifurcations Lesions With Stent: Prospective Randomized Study With Stereoscopic Microscopy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 235
- 试验地点
- 2
- 主要终点
- No damage: the guidewire suffered no loss of integrity over its entire length
研究概览
简要总结
The aims of this study are: 1) To identify more resistant the guidewire type to the retrieval maneuvers after the jailing.
- To determined anatomic and technical factors influencing the induced damage in the guidewire.
Design of the study: prospective randomized study to compare 2 types of guidewire: hydrophilic and no hydrophilic. Patients and methods: Two hundred patients with bifurcation coronary lesions will be included. All of then will be treated by provisional side-branch stenting using the jailed wire technique. One hundred patients will be randomized to hydrophilic wires and another 100 patients to non-hydrophilic wires.
详细描述
The percutaneous approach of bifurcation lesions is a complex procedure; when the stent is implanted at main vessel, a closure of the side-branch may occur. The re-wiring of the side-branch in these conditions may be difficult or even impossible. To facilitate the re-wiring maneuvers the operators use the jailed wired technique. For this technique a guide-wire is introduced in the side-branch before main vessel stent implantation; after the stent deployment the wire remains jailed between the vessel wall and the metallic structure of the stent. If the side-branch became occluded, this wire is a good landmark of it is position, facilitating the access with a new wire. However, the rupture of the wire has been described in some cases, during the retrieval maneuvers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with atherosclerotic coronary disease and bifurcation lesions requiring protection with side branch.
- •The art of imprisoned guide.
- •The main branch should be greater than 2.5 mm in diameter at the operator's visual estimate.
- •The side branch must exceed 2 mm in diameter or have sufficient authority to protect the operator decides with a guide for the release of the main vessel stent.
- •Patients with the above characteristics and main or side branch of any length.
- •Patients with bifurcation lesions with any morphology of the Medina classification: 1 1 1 1 0 1 0 1 1, 110, 001, 010,
- •Treatment of bifurcation with any technique and any type of stent in the side branch meets the criteria above.
- •Symptoms of stable angina or acute coronary syndrome.
排除标准
- •Patients with collateral bouquet of little significance.
- •Patients in cardiogenic shock.
- •Patients in whom it is impossible to guide the placement of the side branch before implantation in the glass principal.
- •Patients who do not give their consent for the study.
结局指标
主要结局
No damage: the guidewire suffered no loss of integrity over its entire length
时间窗: 3 years
Moderate damage: the external cover suffered loss of integrity > 2 mm
时间窗: 3 years
Slight damage: the external cover suffered loss of integrity < 2 mm
时间窗: 3 years
Severe damage: visible changes to the inner cover of the guidewire.
时间窗: 3 years
Fracture: discontinuity at some point along the guidewire
时间窗: 3 years
次要结局
未报告次要终点