Catheter Thrombectomy in Patients With Massive Pulmonary Embolism
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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
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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.
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Primary Endpoints:
- 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.
Secondary Endpoints:
- 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
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 1 Phase 2 |
| Study Type: | Interventional |
| 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%
| 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 |
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
Contacts and Locations| Germany | |
| 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 | |
| Otto-von-Guericke-Universität Magdeburg | |
| Magdeburg, Germany, 39120 | |
| Switzerland | |
| Kantonsspital Luzern | |
| Luzern, Switzerland, 6000 | |
| Principal Investigator: | Nils Kucher, MD | Universitätsspital Zürich (USZ) Switzerland |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00314002 History of Changes |
| Other Study ID Numbers: | APE1 |
| Study First Received: | April 11, 2006 |
| Last Updated: | August 6, 2009 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by Straub Medical AG:
|
Massive pulmonary embolism Catheter thrombectomy |
Additional relevant MeSH terms:
|
Embolism Pulmonary Embolism Embolism and Thrombosis Vascular Diseases |
Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013