NCT04371861已完成不适用
Prospective, Multi-center, Observational, Post-market Study to Assess the Safety and Procedural Success of Performing Transradial Access for Treatment of Atherosclerotic Lesions in the Lower Extremities.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- Radial access site complications
研究概览
简要总结
This study is designed to collect data on the complication rates and procedural success of using a transradial access approach to treat peripheral lesions in the lower extremities of a real world population.
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
- •Rutherford Category 2-5
- •Subject scheduled for a transradial intervention to treat a lesion in the lower extremities.
- •Willing to sign consent and agree to follow-up requirements.
排除标准
- •Previous failed transradial access attempt
- •Presence of or planned dialysis fistula.
- •Planned amputation
- •Previous or planned transradial access intervention +/- 30 days
- •Radial artery diameter <2.5mm
- •No palpable radial artery
- •Established vasospastic disease
- •Known allergy to contrast that cannot be managed
- •Pregnant or lactating
- •Mentally incompetent or a prisoner
- •Currently participating in a clinical study that has not completed it's primary endpoint
结局指标
主要结局
Radial access site complications
时间窗: Procedure
Rates of occurrence in complications associated with transradial access.
Procedural Success
时间窗: Procedure
Successful completion of intended procedure without access complications and without conversion to femoral access.
次要结局
未报告次要终点
研究者
研究点 (8)
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