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.
Study Type
OBSERVATIONAL
Enrollment
81
Medizinische Universität Graz
Graz, Austria
Medizinische Universität Wien
Vienna, Austria
CHU - Hôpital François-Mitterrand
Dijon, Bourgogne-Franche-Comté, France
Universitätsklinikum Aachen
Aachen, Germany
Klinikum Arnsberg, Klinik für Angiologie
Arnsberg, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
Institut für Diagnostische und Interventionelle Radiologie, Universitätsklinik Rostock
Rostock, Germany
Galway University Hospital
Galway, Ireland
Azienda Ospedaliera San Giovanni Addolorata
Roma, Italy
Procedural success (removal of occlusion and restoration of blood flow)
Primary patency
Time frame: day of treatment
Adverse events
failure of usability
Time frame: through study completion of 3 years
Adverse device effects
device related safety variables
Time frame: through study completion of 3 years
Technical success rate
removal of occlusion
Time frame: intraoperative
Swelling of limb
Circumference of the limb
Time frame: through study completion of 3 years
Pain improvement
pain disability index
Time frame: through study completion of 3 years
additional Treatment , acute
index treatment at index site
Time frame: before 72 hours after treatment
additional Treatment, Long term
index treatment at index site
Time frame: later than 72 hours after treatment
Hospital Stay
Duration of hospital stay
Time frame: 4-5 days after treatment
Time to return back to ward
Treatment time
Time frame: day of treatment
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