Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005929

Trial Description

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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

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Trial Acronym

OCCLUDE-II

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URL of the Trial

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Brief Summary in Lay Language

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

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Brief Summary in Scientific Language

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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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005929
  •   2014/08/01
  •   2014/01/08
  •   no
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Secondary IDs

  •   NCT02033954  (ClinicalTrials.gov)
  •   TD 0088 / 02  (ArtVentive Medical Group, Inc.)
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Health Condition or Problem studied

  •   Hemorrhage
  •   Bleeding
  •   R58 -  Haemorrhage, not elsewhere classified
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Interventions/Observational Groups

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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- 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.

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Secondary Outcome

- Occlusion; time frame: 30 days; Sustained occlusion at 30 days follow-up.

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Countries of Recruitment

  •   Austria
  •   Belgium
  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2014/07/31
  •   40
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional 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.

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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.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • ArtVentive Medical Group, Inc.
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    • Universitätsklinikum Giessen und Marburg (UKGM) Klinik für diagnostische und
    • Andreas Mahnken, Prof Dr 
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    • Leon Rudakov, PhD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   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. 2013 May 24. [Epub ahead of print]; 23703667
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   90
  •   2014/11/27
* This entry means the parameter is not applicable or has not been set.