UnknownNot Applicable

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

Austria, Belgium, Germany40 participantsStarted 2014-07

Plain-language summary

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

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Safety

Timeframe: Acute & 30 days

NCT IDNCT02033954

SponsorArtVentive Medical Group, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-12

Leon Rudakov, PhD