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

Study Overview
=================
Brief 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: Stopping blood loss from a damaged blood vessel from a traumatic vascular injury Hemorrhage caused by a neoplasia Neoplastic process (tumor) Gastrointestinal bleeding Closing an abnormal blood vessel supplying a vascular anomaly such as arteriovenous malformations or an arteriovenous fistula Interrupting blood supply to an organ or part of an organ for permanent devascularization Devascularization of tissues involved by a neoplastic process either pre-operatively or as a palliative measure Transjugular Intrahepatic Portosystemic Shunt (TIPS)

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

Conditions
-----------------
Hemorrhage, Bleeding

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects aged ≥18 to ≤75 years. Subject with target vessels of 3.0 mm to 12 mm in diameter. Subject is able and willing to comply with all study requirements, including the required study follow-up visits. Subject or subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the consent form. In the event of emergency procedure and subject and/or legal representative is unable to provide consent prior to study enrollment, consent will be obtained at earliest possible time following procedure for consent to continue to participate in the study. Exclusion Criteria: Subject has a known allergy to iodinated contrast for which they cannot be adequately premedicated. Subjects in whom venography or arteriography is contraindicated. Subjects with known hypersensitivity or contraindication to nickel or nitinol. Subject is pregnant or breastfeeding. Any clinical evidence that the investigator feels would place the subject at increased risk with the deployment of the device.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Acute & 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occlusion | Sustained occlusion at 30 days follow-up. | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Embolization, Hemorrhage, TIPS, GI Bleeding, AV Fistula, AV Malformation, Traumatic Vascular Injury