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

NCT02033954 | Unknown DMC

• 1 other identifier: TD 0088 / 04
• Study Type: observational
• Target: 40
• Locations: 3 countries
• Sites: 7

Brief Summary

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

Conditions

Hemorrhage; Bleeding

Keywords

Embolization; Hemorrhage; TIPS; GI Bleeding; AV Fistula; AV Malformation; Traumatic Vascular Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Occlusion

  30 days

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ArtVentive Medical Group, Inc.: lead

Study Sites (7)

Klinikum Klagenfurt am Worthersee

Klagenfurt, Austria

RECRUITING

Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.

Linz, Austria

NOT YET RECRUITING

UZ Leuven

Leuven, Belgium

NOT YET RECRUITING

Universitatsklinikum Carl Gustav Carus Institut

Dresden, Germany

NOT YET RECRUITING

Universität Leipzig - Department für Bildgebung und Strahlenmedizin

Leipzig, Germany

NOT YET RECRUITING

Universitätsklinikum Giessen und Marburg (UKGM) Klinik für diagnostische und

Marburg, Germany

NOT YET RECRUITING

LMU Klinikum der Universität München, Campus Innenstadt, Interventionelle Radiologie

Munich, Germany

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 23703667 BACKGROUND

MeSH Terms

Conditions

Hemorrhage; Gastrointestinal Hemorrhage; Arteriovenous Fistula; Arteriovenous Malformations

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical

Study Officials

• Andreas Mahnken, Prof Dr

  Universitätsklinikum Giessen und Marburg (UKGM) Klinik für diagnostische und

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leon Rudakov, PhD

CONTACT

+1 (760) 471-7700; leonrudakov@artventivemedical.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 13, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: June 24, 2015

Record last verified: 2015-06

Locations

DE (4); AU (2); BE (1)