Post-Market Evaluation of Active Thrombectomy and Proximal Aspiration During Lower Extremity Tibial Interventions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Primary Endpoint
研究概览
简要总结
Post-Market Evaluation of Active Thrombectomy and Proximal Aspiration during Lower Extremity Tibial Interventions
详细描述
This is a prospective, multi-center, non-randomized, open label, single arm post-market clinical study to gather data on the use of the Protexus catheter for temporary blood vessel occlusion while standard of care treatment with other therapeutic devices is conducted in patients undergoing infrapopliteal treatment for peripheral arterial disease (PAD).
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
- •Subject is at least 18 years of age
- •Subject or authorized representative has signed a written Informed Consent
- •Subject is willing to comply with the protocol requirements
- •Rutherford classification 4-6
- •Planned intervention of the native infrapopliteal arteries using balloon angioplasty, atherectomy, and endovascular procedures.
- •Reference vessel diameter for intended location of the distal tip funnel deployment for the Protexus catheter is ≥3.5mm and ≤6.0mm by visual estimate
- •Inflow arteries have ≤30% stenosis. Inflow arteries can be treated at the time of the study procedure to achieve ≤30% stenosis
排除标准
- •Prior intervention within 30 days of treatment in the planned deployment site for the Protexus catheter
- •Presence of a stent in the planned deployment site for the Protexus catheter
- •Has perforation, dissection, or other injury of the access vessel or Protexus catheter deployment site requiring additional stenting or surgical intervention before enrollment
- •History of bleeding diathesis or coagulopathy and unable to receive standard anticoagulation during the index procedure
- •Acute limb ischemia defined as onset of symptoms within two weeks of the planned intervention
- •Inflow arteries have >30% stenosis after treatment at the time of the study procedure
- •Pregnant female subject or subject that has a positive pregnancy test within the previous 7 days
- •Known hypersensitivity or allergy to nitinol
- •Target blood vessels are infected, have extreme tortuosity, or are occluded with calcified material
结局指标
主要结局
Primary Endpoint
时间窗: 30 Days
The incidence, type, and severity of Protexus related major adverse events (MAEs) through 30-days defined as: * Death or organ injury * Thrombosis, pseudo-aneurysm, dissection (grade C or greater by visual assessment) or clinical perforation at the Protexus device location * Angiographically evident flow limiting distal embolization
次要结局
未报告次要终点