Bleeding Clinical Trial
Official title:
PrOspective, MultiCenter Study for the Evaluation of PerformanCe of the ArtVentive Medical Group Peripheral EndoLuminal OcclUsion SystemTM for the Peripheral Embolization Treatment to Rapidly OccluDe Venous or Arterial BleEding - OCCLUDE II
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)
;
Observational Model: Case-Only, Time Perspective: Prospective
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