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

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

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

Study Overview

• Status: Unknown
• Conditions: Hemorrhage; Bleeding

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)

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Leon Rudakov, PhD; Phone Number: +1 (760) 471-7700; Email: leonrudakov@artventivemedical.com

Study Locations

• Austria
  • Klagenfurt, Austria
    • Recruiting
    • Klinikum Klagenfurt am Wörthersee
    • Contact: Klaus Hausegger, Prof. Dr.; Phone Number: +43 463 538 38 503; Email: Klaus.hausegger@kabeg.at
  • Linz, Austria
    • Not yet recruiting
    • Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.
    • Contact: Peter Waldenberger, Prof Dr; Phone Number: +43 73276777346; Email: Peter.waldenberger@bhs.at
    • Principal Investigator: Peter Waldenberger, Prof Dr
• Belgium
  • Leuven, Belgium
    • Not yet recruiting
    • UZ Leuven
    • Contact: Geert Maleux, Prof Dr; Phone Number: +32 16 34 37 82; Email: geert.maleux@uzleuven.be
    • Principal Investigator: Geert Maleux, Prof Dr
• Germany
  • Dresden, Germany
    • Not yet recruiting
    • Universitatsklinikum Carl Gustav Carus Institut
    • Contact: Ralf Hoffmann, PD Dr.; Phone Number: +49 351 - 458 2259; Email: radiologie@uniklinikum--dresden.de
    • Principal Investigator: Ralf Hoffmann, PD Dr.
  • Leipzig, Germany
    • Not yet recruiting
    • Universität Leipzig - Department für Bildgebung und Strahlenmedizin
    • Contact: Michael Moche, Dr.; Phone Number: +49 341 9717558; Email: Michael.moche@medizin.uni-leipzig.de
  • Marburg, Germany
    • Not yet recruiting
    • Universitätsklinikum Giessen und Marburg (UKGM) Klinik für diagnostische und
    • Contact: Andreas Mahnken, Prof Dr; Phone Number: +49 6421 58-66231; Email: m.treitl@med.unimuenchen.de
    • Principal Investigator: Andreas Mahnken, Prof Dr
  • Munich, Germany
    • Not yet recruiting
    • LMU Klinikum der Universität München, Campus Innenstadt, Interventionelle Radiologie
    • Contact: Marcus Treitl, Prof dr; Phone Number: +49 89-5160-9271; Email: m.treitl@med.unimuenchen.de
    • Principal Investigator: Marcus Treitl, Prof Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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.

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

Collaborators and Investigators

• Sponsor: ArtVentive Medical Group, Inc.
• Investigators: Principal Investigator: Andreas Mahnken, Prof Dr, Universitätsklinikum Giessen und Marburg (UKGM) Klinik für diagnostische und

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: January 8, 2014
• First Submitted That Met QC Criteria: January 10, 2014
• First Posted (Estimate): January 13, 2014

Study Record Updates

• Last Update Posted (Estimate): June 24, 2015
• Last Update Submitted That Met QC Criteria: June 22, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Hemorrhage; TIPS; Embolization; GI Bleeding; AV Fistula; AV Malformation; Traumatic Vascular Injury
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: TD 0088 / 04