Bleeding, Hemorrhage
Conditions
Keywords
Embolization, Hemorrhage, TIPS, GI Bleeding, AV Fistula, AV Malformation, Traumatic Vascular Injury
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: 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)
Interventions
None listed
Sponsors
ArtVentive Medical Group, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects aged ≥18 to ≤75 years. 2. Subject with target vessels of 3.0 mm to 12 mm in diameter. 3. Subject is able and willing to comply with all study requirements, including the required study follow-up visits. 4. 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
1. Subject has a known allergy to iodinated contrast for which they cannot be adequately premedicated. 2. Subjects in whom venography or arteriography is contraindicated. 3. Subjects with known hypersensitivity or contraindication to nickel or nitinol. 4. Subject is pregnant or breastfeeding. 5. Any clinical evidence that the investigator feels would place the subject at increased risk with the deployment of the device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | Acute & 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occlusion | 30 days | Sustained occlusion at 30 days follow-up. |
Countries
Austria, Belgium, Germany
Contacts
Primary ContactLeon Rudakov, PhD
Outcome results
None listed