Compassionate Use of Catheter Thrombectomy (Aspirex 11F) in Patients With Massive Pulmonary Embolism
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 10
- 主要终点
- Immediate decrease in mean pulmonary artery pressure
研究概览
简要总结
Official Title: Compassionate Use of Catheter Thrombectomy (Aspirex 11F) in Patients With Massive Pulmonary Embolism
Study Population: Patients >/= 18 years of age with massive pulmonary embolism suitable for mechanical thrombectomy with Aspirex 11F.
Treatment: Aspirex 11F assisted thrombectomy
The study was terminated early. After having treated seven (7) patients, it was decided in April 2007 that the handling characteristics of the test device should be upgraded before continuing the trial as planned. Therefore, the study was long-term interrupted and finally terminated early. This decision was made by the sponsor in full accordance with the principal investigator. Further studies shall be conducted to show effectiveness and safety of the Aspirex PE catheter thrombectomy device.
Primary Endpoints:
- Thrombectomy with the Aspirex catheter device is associated with an immediate decrease in mean pulmonary artery pressure (PAP) and pulmonary vascular resistance (PVP).
- The Aspirex thrombectomy catheter does not cause perforation/dissection to treated and untreated cardiovascular structures.
Secondary Endpoints:
- Thrombectomy with the Aspirex catheter device is associated with improved flow in the treated main and lobar pulmonary arteries as assessed by the angiographic Miller index.
- There will be no significant mechanical haemolysis as assessed by plasma free haemoglobin levels.
- In-hospital mortality will not exceed 20%.
Study Design: A prospective international multicenter non-randomized registry assessing the safety and efficacy of the Aspirex 11F mechanical thrombectomy device.
Sample Size: Maximum of 50 patients
Inclusion Criteria:
- Patients with massive pulmonary embolism and cardiogenic shock with failed thrombolysis or at least contraindication for lysis.
Exclusion Criteria:
- Systemic embolism in the presence of an arterial septal defect or patent foramen ovale.
- Free floating right heart thrombi, left heart thrombi.
- Life expectancy, due to underlying disease, less than one month.
详细描述
Official Title: Compassionate Use of Catheter Thrombectomy (Aspirex 11F) in Patients With Massive Pulmonary Embolism
Principal Investigator: Nils Kucher, MD, Cardiovascular Division, Interventional Cardiology, Andreas Grüntzig Catheterization Laboratories, Raemistrasse 100 University Hospital Zurich, 8091 Zurich, Switzerland, Phone: +41 1 255 8762, kuchernils@yahoo.com
Sponsor: Straub Medical AG, Straubstrasse, 73 23 Wangs, Schweiz
August 29, 2005
I. BACKGROUND AND SIGNIFICANCE
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >= 18 years of age with pulmonary embolism and cardiogenic shock, defined as a systolic arterial pressure <= 90 mmHg, a drop in systolic arterial pressure >= 40 mmHg for >= 15 minutes, or ongoing administration of catecholamines for systemic arterial hypotension
- •Subtotal or total filling defect in the left and/or right main pulmonary artery due to massive PE, as assessed by chest computed tomography or by conventional pulmonary angiography
- •Right ventricular dysfunction on echocardiography: RV systolic hypokinesis and/or RV dilation (optional)
- •Failed thrombolysis or at least one of the following contraindications to PE thrombolysis present:
- •Active bleeding
- •History of intracranial bleeding
- •Surgery, delivery, organ biopsy, puncture of a non-compressible vessel within 10 days
- •History of stroke
- •Gastrointestinal bleeding within 10 days
- •Significant trauma within 15 days
- •Head injury requiring hospitalization within 1 year
- •Active cancer with known hemorrhagic risk
- •Neurosurgery or ophthalmologic surgery within the past year
- •Platelets < 50,000 or INR >2.0
- •Pregnancy
- •Exclusion Criteria
- •Systemic (paradoxical) embolism in the presence of an atrial septal defect or patent foramen ovale
- •Free floating right heart thrombi, left heart thrombi
- •Life expectancy due to underlying disease less than one month
排除标准
- 未提供
结局指标
主要结局
Immediate decrease in mean pulmonary artery pressure
Technical success
次要结局
- Improved flow in the treated main and lobar pulmonary arteries
- In-hospital mortality will not exceed 20%