A Prospective, Multi-Center Registry, Randomized Trial for Evaluation of Effectiveness of the Blimp Scoring Balloon in Lesions Not Crossable With Conventional Balloon or Microcatheter.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 4
- 主要终点
- Successful crossing through lesion and dilatation with BLIMP or low profile balloon
研究概览
简要总结
The purpose of this study is to investigate the effectivness of the Blimp Scoring balloon compared to current available CTO balloon catheters.
详细描述
For this study two case situations are being considered.
6.1.1 Case Situation A Guidewire crossed the lesion, micro catheter does not cross
Case situation A is the circumstansis where a physician is using a guidewire in combination with a micro catheter. When in such case the guidewire is crossing at a certain moment of the procedure and the micro catheter not a balloon crossing attempt is one of the current common options as next step.
For the study the physician will go through following steps
- select alternating in 50% of these cases his current first choice regular balloon (≤ 1.5 (mm) OD) and in the other 50% of cases the Blimp.
- If first choice regular balloon does not cross select the Blimp and if the Blimp has been first choice select regular first choice balloon.
- If step 2 is not succesfull take a 6F guide extension and repeat sequence of step 1&2.
- If step 3 is also not succesfull report how else succeeded (e.g. tonus, balloon rupture, carlino, rotablation, subintimal cross...) or not.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe coronary lesion where microcatheter or dilatation balloon does not cross
排除标准
- 未提供
结局指标
主要结局
Successful crossing through lesion and dilatation with BLIMP or low profile balloon
时间窗: The primary outcome is a procedural assessment
passing of BLIMP or low profile balloon through lesion. If device passess it will be determined a successful outcome, if it does not pass, an unsuccesful outcome.
次要结局
未报告次要终点
