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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

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

Inclusion criteria

. 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.

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety

Timeframe: Acute & 30 days

Trial details

NCT IDNCT02033954

SponsorArtVentive Medical Group, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-12

Contact for this trial

Leon Rudakov, PhD

+1 (760) 471-7700 leonrudakov@artventivemedical.com

View on ClinicalTrials.gov More Hemorrhage trials