Catheter Thrombectomy in Patients With Massive Pulmonary Embolism
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.
- 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.
- 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
- Patients with massive pulmonary embolism and cardiogenic shock with failed thrombolysis or at least contraindication for lysis.
- 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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Compassionate Use of Catheter Thrombectomy (Aspirex 11F) in Patients With Massive Pulmonary Embolism|
- Immediate decrease in mean pulmonary artery pressure
- Technical success
- Improved flow in the treated main and lobar pulmonary arteries
- In-hospital mortality will not exceed 20%
|Study Start Date:||October 2005|
|Estimated Study Completion Date:||April 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314002
|Herz-Gefässklinik Bad Neustadt|
|Bad Neustadt, Germany, 97616|
|Klinik für Diagnostische Radiologie Christian-Albrechts-Universität Kiel|
|Kiel, Germany, 24105|
|Universität Leipzig Herzzentrum|
|Leipzig, Germany, 04289|
|Magdeburg, Germany, 39120|
|Luzern, Switzerland, 6000|
|Principal Investigator:||Nils Kucher, MD||Universitätsspital Zürich (USZ) Switzerland|