To collect confirmatory data in support of the safety and performance of the ArtVentive Medical Group Endoluminal Occlusion System.
Prospective, non-randomized, multi-center confirmatory observational study for the treatment of subjects with the need for vascular occlusion for the following conditions: 1. Stopping blood loss from a damaged blood vessel from a traumatic vascular injury 2. Hemorrhage caused by a neoplasia 3. Neoplastic process (tumor) 4. Gastrointestinal bleeding 5. Closing an abnormal blood vessel supplying a vascular anomaly such as arteriovenous malformations or an arteriovenous fistula 6. Interrupting blood supply to an organ or part of an organ for permanent devascularization 7. Devascularization of tissues involved by a neoplastic process either pre-operatively or as a palliative measure 8. Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Study Type
OBSERVATIONAL
Enrollment
40
Klinikum Klagenfurt am Worthersee
Klagenfurt, Austria
RECRUITINGKrankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.
Linz, Austria
NOT_YET_RECRUITINGUZ Leuven
Leuven, Belgium
Safety
Composite of new-onset major device-related adverse event(s) including device embolization beyond targeted treatment area (not therapeutic indication of embolization), need for emergency surgical intervention of the target vessel, or distal embolization (non-device embolization, e.g., particulate matter / plague distal to the device) at 30 days.
Time frame: Acute & 30 days
Occlusion
Sustained occlusion at 30 days follow-up.
Time frame: 30 days
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Universitatsklinikum Carl Gustav Carus Institut
Dresden, Germany
NOT_YET_RECRUITINGUniversität Leipzig - Department für Bildgebung und Strahlenmedizin
Leipzig, Germany
NOT_YET_RECRUITINGUniversitätsklinikum Giessen und Marburg (UKGM) Klinik für diagnostische und
Marburg, Germany
NOT_YET_RECRUITINGLMU Klinikum der Universität München, Campus Innenstadt, Interventionelle Radiologie
Munich, Germany
NOT_YET_RECRUITING