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Sponsored by: |
Straub Medical AG |
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Information provided by: | Straub Medical AG |
ClinicalTrials.gov Identifier: | NCT00314002 |
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:
Secondary Endpoints:
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:
Exclusion Criteria:
Condition | Intervention | Phase |
---|---|---|
Pulmonary Embolism |
Device: Mechanical Thrombectomy |
Phase I Phase II |
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 |
Estimated Enrollment: | 50 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | April 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Failed thrombolysis or at least one of the following contraindications to PE thrombolysis present:
Exclusion Criteria
Contact: Nils Kucher, MD | 0041442558762 | nils.kucher@usz.ch |
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 |
Principal Investigator: | Nils Kucher, MD | Universitätsspital Zürich (USZ) Switzerland |
Study ID Numbers: | APE1 |
Study First Received: | April 11, 2006 |
Last Updated: | February 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00314002 |
Health Authority: | Switzerland: Swissmedic |
Massive pulmonary embolism Catheter thrombectomy |
Embolism and Thrombosis Pulmonary Embolism Respiratory Tract Diseases Embolism |
Lung Diseases Vascular Diseases Thrombosis |
Cardiovascular Diseases |