Summary

Eligibility
for people ages 22 years and up (full criteria)
Location
at Irvine 5359777, California 5332921 and other locations
Dates
study started
study ends around

Description

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.

Official Title

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

Details

This is a pivotal, prospective, multi-center, non-randomized, single arm study. This study will enroll patients with active arterial bleeding in the peripheral vasculature confirmed by radiologic and/or endoscopic imaging and deemed suitable for embolization treatment by investigator. In this study, peripheral vasculature is defined as outside of the brain and heart.

Up to 135 subjects will be consented to achieve 119 enrolled at up to 25 sites in the US.

This study will have two visits post-index procedure including hospital discharge visit and 30-day follow-up visit. Reintervention visits will be captured through 30 days post-index procedure.

Keywords

Peripheral Arterial Hemorrhage, Trauma, GI Bleed, Ulcer, Hemorrhage, Embolization treatment, Wounds and Injuries, Gastrointestinal Hemorrhage, Therapeutic Embolization, Onyx™ Liquid Embolic System

Eligibility

You can join if…

Open to people ages 22 years and up

  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.

    In this study, peripheral vasculature is defined as outside the brain and heart.

  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.

You CAN'T join if...

  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.

Locations

  • University of California, Irvine accepting new patients
    Irvine 5359777 California 5332921 92627 United States
  • Stanford Medical Center accepting new patients
    Palo Alto 5380748 California 5332921 94304 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Medtronic Endovascular
ID
NCT06742801
Study Type
Interventional
Participants
Expecting 119 study participants
Last Updated