Safety and Feasibility of the Infinity Guide Catheter for Neuro Interventional Procedures Using Transradial Access
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Feasibility of TRA Intervention
研究概览
简要总结
The main objective of this single arm study is to evaluate the safety and feasibility of the AXS Infinity LS (Stryker, Freemont, CA, USA) and AXS Infinity LS Plus (Stryker, Freemont, CA, USA) catheters during the transradial approach through a secondary use of the data collected during neurointerventional procedures. This includes evaluating the conversion rates to a transfemoral approach. A secondary aim of the study is to assess the radial artery occlusion rates post procedure.
详细描述
Patients who are undergoing endovascular intervention will be enrolled into the study. Consent will be obtained for the procedure and for the use of their prospectively collected clinical data. As the metrics analyzed in this study are already normally collected, this study can be considered as a secondary use of the data. The procedure will be done using standard criteria as per operator preference. All interventional cases at the study institution undergo a "radial first" approach, meaning that the access site of choice is the radial artery. The investigators will measure the radial artery size to ensure that the artery is greater than 2.4 mm in order to use the Infinity catheter (8Fr). If the artery does not meet the size criteria, only a 6Fr sheath will be used, and the data recorded during the procedure will not be utilized for analysis in this study. The preoperative and postoperative care will be the same for all the patients. No tests will be done outside of standard of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 group 18 years and above.
- •Patients undergoing neuro-embolization using large bore catheters
排除标准
- •Patients with Radial artery diameter less than 2.4 mm measured with Ultrasound
- •Patients who have previous surgeries at either approach site which precludes the use of one of the approach sites
- •Patients who has poor collateral circulation, Raynaud's phenomenon, radial loop, brachial or subclavian stenosis, aberrant origin of the subclavian artery
- •Pregnant patients
结局指标
主要结局
Feasibility of TRA Intervention
时间窗: 1 month
The size of the radial artery will be measured and the transradial approach will be used. Notation will be also be recorded if conversion to TFA is used.
次要结局
- Assess radial artery occlusion rates post procedure(1 month)
- Demographics(1 month)
研究者
Priyank Khandelwal, MD
Assistant Professor
Rutgers, The State University of New Jersey