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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02033954
Recruitment Status : Unknown
Verified June 2015 by ArtVentive Medical Group, Inc..
Recruitment status was:  Recruiting
First Posted : January 13, 2014
Last Update Posted : June 24, 2015
Sponsor:
Information provided by (Responsible Party):
ArtVentive Medical Group, Inc.

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

Condition or disease
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)

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
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 Start Date : July 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding




Primary Outcome Measures :
  1. Safety [ Time Frame: 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 Outcome Measures :
  1. Occlusion [ Time Frame: 30 days ]
    Sustained occlusion at 30 days follow-up.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033954


Contacts
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Contact: Leon Rudakov, PhD +1 (760) 471-7700 leonrudakov@artventivemedical.com

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

Additional Information:

Publications:
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Responsible Party: ArtVentive Medical Group, Inc.
ClinicalTrials.gov Identifier: NCT02033954     History of Changes
Other Study ID Numbers: TD 0088 / 04
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015

Keywords provided by ArtVentive Medical Group, Inc.:
Embolization
Hemorrhage
TIPS
GI Bleeding
AV Fistula
AV Malformation
Traumatic Vascular Injury

Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes