Evaluation of Peripheral EOS for the Peripheral Embolization Treatment to Rapidly OccluDe Venous or Arterial BleEding (OCCLUDE-II)

ArtVentive Medical Group

Status: Unknown

Conditions: Hemorrhage; Bleeding

Study type: Observational

Funder types: Industry

Identifiers

NCT02033954

TD 0088 / 04

Details and patient eligibility

About

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

Full 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)

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.