NCT04494035终止不适用
AVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System
Medtronic Endovascular2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2020年1月14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
- 7
- 试验地点
- 2
- 主要终点
- Primary Endpoint (Effectiveness)
研究概览
简要总结
A prospective, single-arm, non-blinded study, intending to treat and collect and evaluate data in up to ten (10) human subjects who are currently being treated with hemodialysis and who present with acute thrombosis in their arteriovenous (AV) grafts, treated with the CAPERE® Thrombectomy System.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •Dialysis patients who are ≥ 18 years of age
- •Dialysis patients with clinical signs, symptoms and presentation consistent with acute thrombosis; onset of symptoms ≤ 14 days
排除标准
- •Dialysis patients who are ≤ 18 years of age.
- •Grafts with aneurysmal degeneration
- •Central venous occlusion
- •Patients with infection of the vascular access
- •Patients with active cancer under current therapy, myeloproliferative syndromes, hyperhomocysteinemia, and heparin-induced thrombocytopenia.
- •Patients with pulmonary embolism (PE) with hemodynamic compromise
- •Any contraindication to systemic or therapeutic doses of heparin or anticoagulants
- •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 (e.g. recent access site creation where there are concerns of leak or disruption of the suture line)
- •Female who is pregnant or nursing
- •Concurrent participation in another investigational drug or device treatment study
结局指标
主要结局
Primary Endpoint (Effectiveness)
时间窗: Intraoperative
Clearance of clot and restoration of blood flow within the affected graft as confirmed via angiographic endpoint in conjunction with a clinical or hemodynamic endpoint
Safety Evaluation
时间窗: 24 Hours
Aggregated major adverse events of \< 5% (events that cannot be adjudicated in less than 24 hours: death, stroke, major bleeding)
次要结局
- Technical Success(Intraoperative)
- Device Safety(Intraoperative)
- Thrombus Removal Rate(Post-procedure)
- 30-Day Patency Rate(30-days)
- Clinical Success(Open)
研究者
研究点 (2)
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