NCT01949779已完成不适用
TransForm™ Occlusion Balloon Catheter Registry
Stryker Neurovascular7 个研究点 分布在 2 个国家目标入组 81 人开始时间: 2013年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 7
- 主要终点
- Catheters Visualized That Reached Intended Target
研究概览
简要总结
The primary objective of this registry is to collect real world data on the safety and performance of the TransForm™ Occlusion Balloon Catheter when used in current neurointerventional procedures
详细描述
- This is a prospective, single-arm, non-randomized, multi-center, observational registry.
- The expected duration for study enrollment is approximately 6 months-1 year.
- Study participation for each subject will be completed upon removal of the guide catheter post-procedure.
- Up to 140 subjects will be enrolled at up to 15 study sites. A given site will be allowed to enroll a maximum of 20 subjects.
- Enrollment in the registry occurs after a signed Informed Consent Form has been obtained, and the index procedure starts.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Subject or legal representative is willing and has provided informed consent.
- •Subject is scheduled to undergo a neurointerventional procedure that may include the use of the occlusion balloon catheter.
- •Subject is over 18 years of age.
排除标准
- •Subject's anatomy precludes safe delivery of the TransForm Occlusion Balloon Catheter.
- •Subject's pregnant
结局指标
主要结局
Catheters Visualized That Reached Intended Target
时间窗: intra-procedure
The number of TransForm™ OBC catheters that reached the intended target location confirmed by angiography visualization.
次要结局
- Angiographic Assessment on Catheter(intra-procedure)
- Procedural Technical Success(post-procedure)
研究者
研究点 (7)
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