Onyx™ Liquid Embolic IDE Clinical Study

Description

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.

Conditions

Peripheral Arterial Hemorrhage, Trauma, GI Bleed, Ulcer, Hemorrhage

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Study Overview

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Study Details

Study overview

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.

PELE IDE Clinical Study, Peripheral Onyx™ Liquid Embolic Safety and Effectiveness of The Onyx™ LES for Embolization of Arterial Hemorrhage in the Peripheral Vasculature

Onyx™ Liquid Embolic IDE Clinical Study

Condition
Peripheral Arterial Hemorrhage
Intervention / Treatment

-

Contacts and Locations

Aurora

UCHealth University of Colorado Hospital, Aurora, Colorado, United States, 80045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Patient is ≥ 22 years old.
  • 2. Active arterial bleeding in the peripheral vasculature confirmed by radiologic and/or endoscopic imaging and deemed suitable for embolization treatment by the investigator.
  • 3. Patient or legally authorized representative (LAR) is able to provide written consent to participate in the study.
  • 4. Life expectancy of \>30 days, in the opinion of the investigator at the time of enrollment.
  • 5. Target treatment area is free from prior embolization treatment.
  • 1. Pregnant or breastfeeding.
  • 2. Symptoms of active infection.
  • 3. Patient is known to be participating in the study of an investigational drug, biologic, or device.
  • 4. Contrast allergy or other contraindication to angiography, CT, or catheterization, including contrast sensitivity that cannot be adequately treated prior to index procedure.
  • 5. Known allergy to components of Onyx™.
  • 6. Target vasculature unsuitable for the delivery of Onyx™ based upon physician assessment.
  • 7. More than 4 target lesions will require embolization, in the investigator's opinion after imaging-based assessment.

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medtronic Endovascular,

Osman Ahmed, MD, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

2026-12