NCT02033954

Evaluation of Peripheral EOS for the Peripheral Embolization Treatment to Rapidly OccluDe Venous or Arterial BleEding

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: ArtVentive Medical Group, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To collect confirmatory data in support of the safety and performance of the ArtVentive Medical Group Endoluminal Occlusion System.

Detailed description

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)

Conditions

• Hemorrhage
• Bleeding

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-12-01
• Completion: 2016-01-01
• First posted: 2014-01-13
• Last updated: 2015-06-24

Locations

7 sites across 3 countries: Austria, Belgium, Germany