NCT04949048已完成不适用
Evaluation of the Safety and Performance of Magneto PE Kit for Endovascular Thrombectomy in Patients With Acute Pulmonary Embolism
Magneto Thrombectomy Solutions7 个研究点 分布在 3 个国家目标入组 15 人开始时间: 2021年8月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 7
- 主要终点
- Assessment of the safety of Magneto PE Kit
研究概览
简要总结
This study is designed as a prospective, multi-center, multinational open labeled, single armed study to evaluate the safety and performance of the Magneto PE Kit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical signs, symptoms and presentation consistent with acute PE
- •PE symptom duration ≤ 14 days
- •CTA evidence of PE
- •RV/LV ratio ≥ 0.9
- •Heart rate <130 BPM prior to procedure
- •Subject medically eligible for interventional procedure
- •Age ≥ 18 and <75 years
- •Consent process is completed
排除标准
- •Thrombolytic use within 14 days
- •Known bleeding diathesis or coagulation disorder
- •Any contraindication to systemic therapeutic doses of heparin or other anticoagulants
- •Hemodynamic collapse at presentation
- •Decompensated heart failure
- •Presence of Extra-Corporeal Membrane Oxygenation.
- •Major trauma ISS> 15 within 14 days
- •Cardiovascular or pulmonary surgery within last 7 days
- •FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%
- •Hematocrit < 28%
- •Platelets < 100,000/µL
- •Serum creatinine > 1.8 mg/dL
- •Left bundle branch block
- •PAP > 70 mmHg m
- •Imaging evidence suggests subject is not appropriate for mechanical thrombectomy
- •Presence of intracardiac lead in right ventricle or atrium.
- •Pacemaker or Implantable Cardioverter Defibrillator
- •Presence of intracardiac thrombus
- •Anaphylactic reaction to radiographic contrast agents that cannot be pre-treated
- •Known right- to-left shunt,
- •Known left ventricular ejection fraction ≤ 30%
- •History of severe chronic pulmonary arterial hypertension
- •History of underlying lung disease with oxygen dependence
- •History of chest irradiation
- •History of Heparin Induced Thrombocytopenia (HIT)
- •Female who is pregnant or nursing
- •Current participation in another investigational drug or device treatment study
- •Life expectancy of < 90 days as determined by the investigator
- •Subjects who are intubated
研究组 & 干预措施
Magneto PE Kit
Experimental
Treatment with Magneto PE Kit
干预措施: Magneto PE Kit (Device)
结局指标
主要结局
Assessment of the safety of Magneto PE Kit
时间窗: 48 (±8) hours
Number of patients with a composite of major adverse events within 48 (± 8) hours of the index procedure
次要结局
- Assessment of the safety of Magneto PE Kit(30 (±3) days)
- Assessment of ease of use during the procedure(Procedure)
- Assessment of the impact on RV dysfunction (RV/LV ratio)(48 (±8) hours)
研究者
研究点 (7)
Loading locations...
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