NCT03869645终止不适用
CAPERE Thrombectomy System Post-Market Clinical Follow Up Study
Medtronic Endovascular3 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2019年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- Restoration of blood flow
研究概览
简要总结
A prospective, single-arm, non-blinded study, intending to collect and evaluate data in up to forty (40) human subjects with acute thrombosis, treated with the CAPERE™ Thrombectomy System.
详细描述
A prospective, single-arm, non-blinded study, intending to collect and evaluate data in up to forty (40) human subjects with acute thrombosis, treated with the CAPERE™ Thrombectomy System.
Subjects will be evaluated based on VEINES QoL survey pre- and post-treatment (30-days).
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
- •Patients who are greater than or equal to 18 years of age
- •Patients with clinical signs, symptoms and presentation consistent with acute thrombosis; onset of symptoms < 14 days
- •Patients cleared medically for invasive endovenous procedures
排除标准
- •Patients with IVC filter in area to be treated
- •Patients who are < 18 years of age.
- •Known anaphylactic reaction of radiographic contrast agents that cannot be pre- treated
- •Imaging evidence or other evidence that suggests the participant is not appropriate for mechanical thrombectomy intervention
- •Female who is pregnant or nursing
- •Concurrent participation in another investigational drug or device treatment study
结局指标
主要结局
Restoration of blood flow
时间窗: Day 0 - Intervention
Clearance of clot and restoration of venous flow of the affected vessel as confirmed using venogram immediately post-procedure
次要结局
- Device Success(Day 0)
- Technical Success Rate(Day 0)
- Thrombus removal rate(Day 0)
- Safety Endpoint(30 days)
- VEINES Survey(</= Day 0 and Day 30)
研究者
研究点 (3)
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