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Catheter Thrombectomy in Patients With Massive Pulmonary Embolism
This study is currently recruiting participants.
Verified by Straub Medical AG, April 2006
First Received: April 11, 2006   Last Updated: February 21, 2007   History of Changes
Sponsored by: Straub Medical AG
Information provided by: Straub Medical AG
ClinicalTrials.gov Identifier: NCT00314002
  Purpose

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

Primary Endpoints:

  1. Thrombectomy with the Aspirex catheter device is associated with an immediate decrease in mean pulmonary artery pressure (PAP) and pulmonary vascular resistance (PVP).
  2. The Aspirex thrombectomy catheter does not cause perforation/dissection to treated and untreated cardiovascular structures.

Secondary Endpoints:

  1. 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.
  2. There will be no significant mechanical haemolysis as assessed by plasma free haemoglobin levels.
  3. 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.

Condition Intervention Phase
Pulmonary Embolism
 Device: Mechanical Thrombectomy
 Phase I
Phase II

MedlinePlus related topics: Pulmonary Embolism
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Compassionate Use of Catheter Thrombectomy (Aspirex 11F) in Patients With Massive Pulmonary Embolism

Further study details as provided by Straub Medical AG:

Primary Outcome Measures:
  • Immediate decrease in mean pulmonary artery pressure
  • Technical success

Secondary Outcome Measures:
  • Improved flow in the treated main and lobar pulmonary arteries
  • In-hospital mortality will not exceed 20%

Estimated Enrollment: 50
Study Start Date: October 2005
Estimated Study Completion Date: April 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314002

Contacts
Contact: Nils Kucher, MD 0041442558762 nils.kucher@usz.ch

Locations
Germany
Universität Leipzig Herzzentrum Recruiting
Leipzig, Germany, 04289
Contact: Dierk Scheinert, MD     00493418651478     sched@medizin.uni-leipzig.de    
Principal Investigator: Dierk Scheinert, MD            
Sub-Investigator: Andrej Schmidt, MD            
Klinik für Diagnostische Radiologie Christian-Albrechts-Universität Kiel Recruiting
Kiel, Germany, 24105
Contact: Stefan Müller-Hülsbeck, MD     +49 (0431) 5974434     muehue@rad.uni-kiel.de    
Principal Investigator: Stefan Müller-Hülsbeck, MD            
Herz-Gefässklinik Bad Neustadt Recruiting
Bad Neustadt, Germany, 97616
Contact: Eberhard K. Wedell, MD     0049 9771 66 2563     ewedell@t-online.de    
Principal Investigator: Eberhard K. Wedell, MD            
Otto-von-Guericke-Universität Magdeburg Recruiting
Magdeburg, Germany, 39120
Contact: Jens Ricke, MD     +49 391 6713030     Jens.Ricke@Medizin.Uni-Magdeburg.de    
Principal Investigator: Jens Ricke, MD            
Switzerland
Kantonsspital Luzern Recruiting
Luzern, Switzerland, 6000
Contact: Paul Erne, MD     +41 (041) 2051111     Paul.Erne@ksl.ch    
Principal Investigator: Paul Erne, MD            
Sponsors and Collaborators
Straub Medical AG
Investigators
Principal Investigator: Nils Kucher, MD Universitätsspital Zürich (USZ) Switzerland
  More Information

Publications:
Kucher N, Windecker S, Banz Y, Schmitz-Rode T, Mettler D, Meier B, Hess OM. Percutaneous catheter thrombectomy device for acute pulmonary embolism: in vitro and in vivo testing. Radiology. 2005 Sep;236(3):852-8. Epub 2005 Jul 12.

Study ID Numbers: APE1
Study First Received: April 11, 2006
Last Updated: February 21, 2007
ClinicalTrials.gov Identifier: NCT00314002     History of Changes
Health Authority: Switzerland: Swissmedic

Keywords provided by Straub Medical AG:
Massive pulmonary embolism
Catheter thrombectomy

Study placed in the following topic categories:
Embolism and Thrombosis
Pulmonary Embolism
Respiratory Tract Diseases
Embolism
 Lung Diseases
Vascular Diseases
Thrombosis

Additional relevant MeSH terms:
Embolism and Thrombosis
Pulmonary Embolism
Respiratory Tract Diseases
Embolism
 Lung Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009



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