Evaluation of Radial Access for Neurointerventional Procedures Using the RIST Radial Access System in an Indian Neurovascular Center
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The primary outcome of the study is the effectiveness of catheterization using the RIST radial access
研究概览
简要总结
This is a prospective single center observational study being conducted at Artemis Hospital, Gurugram, India. The study will enroll 100 patients (older than 12 years) undergoing elective or emergency neurointerventional procedures using the RIST Radial Access System. The primary aim is to assess catheterization success via transradial access without conversion to another route. Secondary objectives include evaluating procedural success rates and safety outcomes such as radial artery spasm, occlusion, hematoma, and procedure-related complications. Data will be collected until hospital discharge using an electronic CRF. The study is investigator-initiated, self-funded, and will follow ICH GCP and local ethical guidelines. Results will provide important evidence on the feasibility and safety of RIST device use in Indian neurovascular practice
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 12.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 12 years or older.
- •The presence of an adequate radial artery diameter, defined as greater than equal to 1.7 mm, as confirmed through pre-procedural ultrasound evaluation.
- •Patients who have undergone procedure by RIST series of catheter.
- •Favorable aortic arch anatomy, assessed via computed tomography angiography (CTA) or digital subtraction angiography (DSA), deemed suitable for radial access.
- •Willing to provide written informed consent.
排除标准
- •Presence of severe peripheral vascular disease or anatomical abnormalities of the radial artery e.g., radial artery loop that may hinder safe catheter navigation.
- •History of previous ipsilateral radial artery occlusion.
- •Contraindications to radial access, such as significant arterial calcification or vasospasm identified on ultrasound imaging.
结局指标
主要结局
The primary outcome of the study is the effectiveness of catheterization using the RIST radial access
时间窗: Baseline Procedure
system. Catheterization will be considered effective if the operator is able to navigate the Rist catheter
时间窗: Baseline Procedure
to the desired target vessel via TRA without crossover to an alternate access site
时间窗: Baseline Procedure
次要结局
- 1. Procedural success rate: Defined as the ability to complete the intracranial portion of the procedure(without switching to a different access site or guide catheter.)
研究者
Dr Tariq Matin
Artemis Hospitals