Status:
TERMINATED
Catheter Thrombectomy in Patients With Massive Pulmonary Embolism
Lead Sponsor:
Straub Medical AG
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 su...
Detailed Description
Official Title: Compassionate Use of Catheter Thrombectomy (Aspirex 11F) in Patients With Massive Pulmonary Embolism Principal Investigator: Nils Kucher, MD, Cardiovascular Division, Interventional C...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00314002
Start Date
October 1 2005
End Date
April 1 2007
Last Update
August 7 2009
Active Locations (5)
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1
Herz-Gefässklinik Bad Neustadt
Bad Neustadt an der Saale, Germany, 97616
2
Klinik für Diagnostische Radiologie Christian-Albrechts-Universität Kiel
Kiel, Germany, 24105
3
Universität Leipzig Herzzentrum
Leipzig, Germany, 04289
4
Otto-von-Guericke-Universität Magdeburg
Magdeburg, Germany, 39120