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The ASPIREX®S Endovascular System is a rotating and aspirating catheter system. It is intended to be used for the percutaneous transluminal removal of fresh thrombotic or thromboembolic material from native blood vessels (or vessels fitted with stents, stent grafts or native or artificial bypasses) outside the cardiopulmonary, coronary and cerebral circulations.
CAPTUREX® , a catheter with a filter basket, is intended to be used for the filtering of emboli from blood vessels during potentially embolizing procedures on the patient.
ASPIREX®S and CAPTUREX® are CE-marked (Class III) medical devices. In this study the effectiveness and safety in the removal of thrombi in veins is assessed under real life setting.
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| Measure | Description | Time Frame |
|---|---|---|
| Procedural success (removal of occlusion and restoration of blood flow) | Primary patency | day of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | failure of usability | through study completion of 3 years |
| Adverse device effects | device related safety variables | through study completion of 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Main study population: patients with DVT of the pelvis, legs and vena cava inferior.
Additional patients with dialysis shunts and / or other bypasses, vena subclavia, vena brachiocephalica, vena cava superior, vena splenica and vena mesenterica superior/inferior will be included
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Graz | Graz | Austria | ||||
| Medizinische Universität Wien |
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| Technical success rate | removal of occlusion | intraoperative |
| Swelling of limb | Circumference of the limb | through study completion of 3 years |
| Pain improvement | pain disability index | through study completion of 3 years |
| additional Treatment , acute | index treatment at index site | before 72 hours after treatment |
| additional Treatment, Long term | index treatment at index site | later than 72 hours after treatment |
| Hospital Stay | Duration of hospital stay | 4-5 days after treatment |
| Time to return back to ward | Treatment time | day of treatment |
| Vienna |
| Austria |
| CHU - Hôpital François-Mitterrand | Dijon | Bourgogne-Franche-Comté | 21079 | France |
| Universitätsklinikum Aachen | Aachen | Germany |
| Klinikum Arnsberg, Klinik für Angiologie | Arnsberg | 59755 | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | Germany |
| Institut für Diagnostische und Interventionelle Radiologie, Universitätsklinik Rostock | Rostock | 18057 | Germany |
| Galway University Hospital | Galway | H91YR71 | Ireland |
| Azienda Ospedaliera San Giovanni Addolorata | Roma | Italy |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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