RecruitingNot Applicable

Onyx™ Liquid Embolic IDE Clinical Study

United States119 participantsStarted 2025-05-09

Plain-language summary

The purpose of this study is to evaluate the safety and effectiveness of Onyx™ LES in the treatment of subjects with active arterial bleeding in the peripheral vasculature outside of the heart and brain.

Who can participate

Age range22 Years

SexALL

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Inclusion criteria

✓. Patient is ≥ 22 years old.
✓. Active arterial bleeding in the peripheral vasculature confirmed by radiologic and/or endoscopic imaging and deemed suitable for embolization treatment by the investigator.
✓. Patient or legally authorized representative (LAR) is able to provide written consent to participate in the study.
✓. Life expectancy of \>30 days, in the opinion of the investigator at the time of enrollment.
✓. Target treatment area is free from prior embolization treatment.

Exclusion criteria

✕. Pregnant or breastfeeding.
✕. Symptoms of active infection.
✕. Patient is known to be participating in the study of an investigational drug, biologic, or device.
✕. Contrast allergy or other contraindication to angiography, CT, or catheterization, including contrast sensitivity that cannot be adequately treated prior to index procedure.
✕. Known allergy to components of Onyx™.
✕. Target vasculature unsuitable for the delivery of Onyx™ based upon physician assessment.
✕. More than 4 target lesions will require embolization, in the investigator's opinion after imaging-based assessment.

What they're measuring

Freedom from Arterial Hemorrhage

Timeframe: Through 30 days post-index procedure

Freedom from System-related Major Adverse Events (MAE)

Timeframe: Through 30 days post-index procedure

Trial details

NCT IDNCT06742801

SponsorMedtronic Endovascular

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04

Contact for this trial

Janki Shah

7322662503 janki.shah@medtronic.com

View on ClinicalTrials.gov More Peripheral Arterial Hemorrhage trials