Trial document

This study has been imported from without additional data checks.
drksid header


Trial Description

start of 1:1-Block 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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym


end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial


end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

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

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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

7. Devascularization of tissues involved by a neoplastic process either pre-operatively or
as a palliative measure

8. Transjugular Intrahepatic Portosystemic Shunt (TIPS)

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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


end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:


end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00005929
  •   2014/08/01
  •   2014/01/08
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT02033954  (
  •   TD 0088 / 02  (ArtVentive Medical Group, Inc.)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Hemorrhage
  •   Bleeding
  •   R58 -  Haemorrhage, not elsewhere classified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  • [---]*
end of 1:N-Block interventions
start of 1:1-Block design


  •   Non-interventional
  •   Observational study
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

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.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

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

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Austria
  •   Belgium
  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

end of 1:n-Block recruitment locations
start of 1:1-Block recruitment


  •   [---]*
  •   2014/07/31
  •   40
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

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.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

1. Subject has a known allergy to iodinated contrast for which they cannot be adequately

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.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses


  • start of 1:1-Block address primary-sponsor
    • ArtVentive Medical Group, Inc.
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Giessen und Marburg (UKGM) Klinik für diagnostische und
    • Andreas Mahnken, Prof Dr 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Leon Rudakov, PhD 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state


  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

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
end of 1:n-Block publications
The parameters in and DRKS are not identical. Therefore the data import from 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.