Onyx™ Liquid Embolic IDE Clinical Study

June 2, 2026 updated by: Medtronic Endovascular

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

119

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Contact:
          • Xavier Lopez
        • Principal Investigator:
          • Sadeer Alzubaidi, MD
    • California
      • Irvine, California, United States, 92627
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Medical Center
        • Contact:
          • Andrew Picel, MD
        • Contact:
          • Meredith Durbahn
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • UCHealth University of Colorado Hospital
        • Contact:
        • Principal Investigator:
          • Eduardo Bent Robinson, MD
    • Connecticut
    • Illinois
      • Chicago, Illinois, United States, 60637
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Hospitals and Clinics
        • Principal Investigator:
          • Michael Hummel, MD
        • Contact:
          • Judith Pena Quevedo, AGNP-C, CCRC
    • Massachusetts
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • Recruiting
        • CHI Health Creighton University Medical Center-Bergan-Mercy
        • Contact:
        • Principal Investigator:
          • Patrick Harty
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Recruiting
        • Rutgers New Jersey Medical School
        • Principal Investigator:
          • Abhishek Kumar, MD
        • Contact:
    • New York
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center
        • Contact:
        • Principal Investigator:
          • Salim Abboud, MD
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Contact:
          • Mina Makary, MD
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15237
        • Recruiting
        • University of Pittsburgh Medical Center
        • Principal Investigator:
          • Paula Novelli, MD
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
        • Principal Investigator:
          • Anthony Borgmann, MD
    • Texas
      • Dallas, Texas, United States, 75235
        • Recruiting
        • Univ Of Texas Southwestern
        • Principal Investigator:
          • Sanjeeva Kalva, MD
        • Contact:
      • Houston, Texas, United States, 77030

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion 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.

    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.

Exclusion Criteria:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment with Onyx LES
Device; embolization with liquid embolic
Device: Onyx™ Liquid Embolic System
The proposed indication for Onyx™ LES is: Onyx™ LES is indicated for the embolization of arterial hemorrhage in the peripheral vasculature.
Other Names:
  • Embolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from Arterial Hemorrhage
Time Frame: Through 30 days post-index procedure
Freedom from arterial hemorrhage in all target location(s) after treatment with Onyx™ LES at the index procedure without re-embolization or any other intervention at the target location(s) due to persistent or recurrent hemorrhage through 30 days. Freedom from arterial hemorrhage where an arterial hemorrhage event is defined as a type 3 or greater BARC bleeding criteria as assessed by the Clinical Events Committee (CEC) through 30 days.
Through 30 days post-index procedure
Freedom from System-related Major Adverse Events (MAE)
Time Frame: Through 30 days post-index procedure
The primary safety endpoint is defined as freedom from system-related Major Adverse Events (MAE) through 30 days after the point of enrollment as assessed by the CEC.
Through 30 days post-index procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural Success
Time Frame: At the completion of the index procedure
successful delivery and deployment of Onyx™ to the target location without non-target embolization or Onyx™ cast migration and the successful removal of the delivery system at the completion of the index procedure.
At the completion of the index procedure
Technical Success
Time Frame: At the completion of the index procedure
Technical Success is defined as absence of angiographic signs of bleeding after Onyx ™ embolization at each target location based on core lab assessment.
At the completion of the index procedure
Reintervention
Time Frame: Through 30 days post-index procedure
Reintervention is defined as the number of additional procedures needed to treat the target location(s) embolized with Onyx™ through 30 days following the index procedure.
Through 30 days post-index procedure
Transfusions
Time Frame: Through 30 days post-index procedure
Transfusions defined as the number of blood transfusions required post-index procedure through 30 days will use blood transfusions starting after the removal of the delivery system. The number of blood units used for each transfusion will also be collected.
Through 30 days post-index procedure

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ancillary Endpoint
Time Frame: Through index procedure
Duration of the index procedure
Through index procedure
Ancillary Endpoint
Time Frame: Through 30 days post-index procedure
Length of hospitalization, post-index procedure
Through 30 days post-index procedure
Ancillary Endpoint
Time Frame: Through 30 days post-index procedure
Tabulate adjunctive use of other types of embolic agents to treat target locations at index procedure and reinterventions
Through 30 days post-index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Endovascular

Investigators

  • Principal Investigator: Osman Ahmed, MD, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

December 11, 2024

First Submitted That Met QC Criteria

December 18, 2024

First Posted (Actual)

December 19, 2024

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDT21044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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