Balloon Guide Versus Conventional Guide Catheter in Stroke Thrombectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 186
- 试验地点
- 3
- 主要终点
- TICI Grading Scale Score
研究概览
简要总结
The purpose of this clinical trial is to study the two main types of approaches used in stroke thrombectomy and to investigate if one approach is more effective than the other, as this is currently not known. This study will be conducted in adults who have been diagnosed with an acute ischemic stroke and who are undergoing a thrombectomy for the treatment of their stroke. The main questions it aims to answer are:
- Does the use of a balloon guide catheter versus a conventional guide catheter lower the time needed to restore blood flow in the blocked vessel in the brain
- To help researchers better understand the technical, clinical, and procedural outcomes associated with using a balloon guide catheter versus a conventional guide catheter in stroke thrombectomy
Participants will be asked to
- Share their medical history and imaging data that is collected as part of their routine medical care
- Undergo a mechanical thrombectomy as part of their routine medical care
- Answer some questions about their neurological functioning at 3 months (90 days) post hospitalization
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Age 18 years or older
- •Patient is undergoing a stroke thrombectomy procedure at the enrolling hospital
- •Patient or the legally authorized representative are able to provide signed informed cosent for the study
- •Patient is not enrolled in another clinical trial that may interfere with the results or interpretation of this study
- •Identification of a Large Vessel Occlusion (LVO) on imaging
排除标准
- •Lack of signed informed consent from the patient or legally authorized representative
- •Spontanous recanalization or any other reason in which the mechanical thrombectomy procedure would be terminated
研究组 & 干预措施
Balloon Guide Catheter
Use of a balloon guide catheter in stroke thrombectomy.
干预措施: Use of a Balloon Guide Catheter (Other)
Conventional Guide Catheter
Use of conventional (non-balloon guide) catheter in stroke thrombectomy.
干预措施: Use of a Conventional (non-balloon) Guide Catheter (Other)
结局指标
主要结局
TICI Grading Scale Score
时间窗: Participant duration is 90 days.
Use of a mTICI grading scale to look at the degree to which the vessel has been opened during a mechanical thrombectomy.
次要结局
- Number of Participants with Treatment Related Adverse Effects(Participant duration is 90 days.)
- Procedural Outcomes(Participant duration is 90 days.)