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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-01-31

Brief Summary

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

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Detailed Description

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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)

Conditions

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Hemorrhage Bleeding

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andreas Mahnken, Prof Dr

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Giessen und Marburg (UKGM) Klinik für diagnostische und

Locations

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Klinikum Klagenfurt am Worthersee

Klagenfurt, , Austria

Site Status RECRUITING