Catheter Thrombectomy in Patients With Massive Pulmonary Embolism

Launched by STRAUB MEDICAL AG · Apr 11, 2006

Keywords

ClinConnect Summary

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

A) Historical Background

Acute pulmonary embolism (PE) is a potentially life-threatening disease with an ove...

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Eligibility criteria

• Inclusion Criteria:
• • 1. 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
• • 2. 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
• • 3. Right ventricular dysfunction on echocardiography: RV systolic hypokinesis and/or RV dilation (optional)
• 4. 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
• • 1. Systemic (paradoxical) embolism in the presence of an atrial septal defect or patent foramen ovale
• • 2. Free floating right heart thrombi, left heart thrombi
• • 3. Life expectancy due to underlying disease less than one month