Clinical trial NCT02033954: Evaluation of Peripheral EOS for the Peripheral Embolization Treatment to Rapidly OccluDe Venous or Arterial BleEding
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemorrhage
Bleeding
Keywords: Embolization
Hemorrhage
TIPS
GI Bleeding
AV Fistula
AV Malformation
Traumatic Vascular Injury
Lead sponsor: ArtVentive Medical Group, Inc.
Sponsor class: INDUSTRY
First posted: 2014-01-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects requiring permanent occlusion of the peripheral vessels 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)

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Safety
timeFrame: Acute & 30 days
Secondary outcomes:
measure: Occlusion
timeFrame: 30 days
Other outcomes:
Locations:
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt am Worthersee
city: Linz
country: Austria
facility: Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.
city: Leuven
country: Belgium
facility: UZ Leuven
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustav Carus Institut
city: Leipzig
country: Germany
facility: Universität Leipzig - Department für Bildgebung und Strahlenmedizin
city: Marburg
country: Germany
facility: Universitätsklinikum Giessen und Marburg (UKGM) Klinik für diagnostische und
city: Munich
country: Germany
facility: LMU Klinikum der Universität München, Campus Innenstadt, Interventionelle Radiologie
Study officials:
affiliation: Universitätsklinikum Giessen und Marburg (UKGM) Klinik für diagnostische und
name: Andreas Mahnken, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Venbrux AC, Rudakov L, Plass A, Emmert MY, Ebner A. A new occlusion device: application of the ArtVentive endoluminal occlusion system (EOS)--first in human clinical trial. Cardiovasc Intervent Radiol. 2014 Feb;37(1):85-93. doi: 10.1007/s00270-013-0626-y. Epub 2013 May 24.