Onyx™ Liquid Embolic IDE Clinical Study
PELE IDE Clinical Study, Peripheral Onyx™ Liquid Embolic Safety and Effectiveness of The Onyx™ LES for Embolization of Arterial Hemorrhage in the Peripheral Vasculature
1 other identifier
interventional
119
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2025
Typical duration for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2024
CompletedFirst Posted
Study publicly available on registry
December 19, 2024
CompletedStudy Start
First participant enrolled
May 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
May 1, 2026
April 1, 2026
1.9 years
December 11, 2024
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Freedom from Arterial Hemorrhage
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)
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 Outcomes (4)
Procedural Success
At the completion of the index procedure
Technical Success
At the completion of the index procedure
Reintervention
Through 30 days post-index procedure
Transfusions
Through 30 days post-index procedure
Other Outcomes (3)
Ancillary Endpoint
Through index procedure
Ancillary Endpoint
Through 30 days post-index procedure
Ancillary Endpoint
Through 30 days post-index procedure
Study Arms (1)
Treatment with Onyx LES
EXPERIMENTALDevice; embolization with liquid embolic
Interventions
The proposed indication for Onyx™ LES is: Onyx™ LES is indicated for the embolization of arterial hemorrhage in the peripheral vasculature.
Eligibility Criteria
You may qualify if:
- 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.
- In this study, peripheral vasculature is defined as outside the brain and heart.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Mayo Clinic
Phoenix, Arizona, 85054, United States
University of California, Irvine
Irvine, California, 92627, United States
Stanford Medical Center
Palo Alto, California, 94304, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045, United States
Yale New Haven
New Haven, Connecticut, 06510, United States
University of Chicago
Chicago, Illinois, 60637, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Masschusetts General Hospital
Boston, Massachusetts, 02114, United States
CHI Health Creighton University Medical Center-Bergan-Mercy
Omaha, Nebraska, 68124, United States
Albany Medical Center
Albany, New York, 12208, United States
The Mount Sinai
New York, New York, 10029, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Univ Of Texas Southwestern
Dallas, Texas, 75235, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Osman Ahmed, MD
University of Chicago
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2024
First Posted
December 19, 2024
Study Start
May 9, 2025
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share