NCT04144959已完成不适用
STRIDE: A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo Aspiration System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 17
- 主要终点
- Target Limb Salvage Rate
研究概览
简要总结
The primary objective of this study is to collect safety and performance data on the Indigo Aspiration System in a patient population with lower extremity acute limb ischemia (LE ALI).
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
- •Patient age ≥ 18
- •Patient presents with acute (≤14 days) occlusion of lower limb artery(ies) (below inguinal ligament)
- •Patient with a Rutherford Category I, IIa or IIb score
- •Frontline treatment with Indigo Aspiration System
- •Informed consent is obtained from either patient or legally authorized representative (LAR)
排除标准
- •Life expectancy <1 year
- •Vessel size <2 mm
- •LE ALI secondary to dissections, vasculitis, and/or target vessel trauma
- •Amputation in the ipsilateral limb
- •Pregnancy or positive pregnancy test according to site specific standards of care (only required for women of child bearing potential, serum or urine acceptable)
- •Absolute contraindication to contrast administration
- •Patient is unwilling or unable to comply with protocol follow up schedule and/or based on the Investigator's judgment the patient is not a good study candidate
- •Currently participating in an investigational drug or device clinical trial that may confound the study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.
结局指标
主要结局
Target Limb Salvage Rate
时间窗: 1-Month Post Procedure
Proportion of participants who did not have a major amputation (above the level of the tarsometatarsal joint)
次要结局
- Technical Success(Immediate Post Procedure)
- Modified Society for Vascular Surgery Runoff Score(Pre Procedure and immediately Post Procedure)
- Improvement of Rutherford Classification(Up to discharge or 7 days, whichever occurred first)
- Vessel Patency(1-Month Post-Procedure)
- Target Limb Salvage Rate(12-Months Post Procedure)
- Rates of Device Related Serious Adverse Events (SAEs)(Up until study completion, at approximately 12-Months)
- Major Bleeding Peri-procedure(within 2 days of procedure)
- Mortality(12-Months)
研究者
研究点 (17)
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