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Peripheral Arterial HemorrhageNCT06742801

Onyx™ Liquid Embolic IDE Clinical Study

A study testing Onyx™ Liquid Embolic System in people with Peripheral Arterial Hemorrhage and Trauma, run by Medtronic Endovascular at 20 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Peripheral Arterial Hemorrhage, Trauma, GI Bleed
What is being tested?
Onyx™ Liquid Embolic System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
119 participants
Where
20 sitesUnited States
Study dates
9 May 2025to May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Janki Shah contact

7322662503

janki.shah@medtronic.com

Liza Marie contact

7072172314

liza.marie@medtronic.com

20 sites in 1 country

United States20 sites, 20 recruiting

  • Albany Medical Center

    Albany, New York, 12208

    Gary Siskin, MD, sisking@amc.edu

    Nancy Spencer, NP, spencen@amc.edu

    Recruiting

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

    Alejandra Aguilar, MPH, alejandra.aguilar@cuanschutz.edu

    Eduardo Bent Robinson, MD

    Recruiting

  • Masschusetts General Hospital

    Boston, Massachusetts, 02114

    Vincent Wu, MD, vwu3@mgh.harvard.edu

    Justin Hill, jhill43@mgh.harvard.edu

    Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

    Adriana Delgado, adriana_delgado@med.unc.edu

    Nima Kokabi, MD

    Recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Tiana Jackson, tiana.jackson@bsd.uchicago.edu

    Brian Funaki, MD

    Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    Lauren Hahn, lauren.hahn@uhhospitals.org

    Salim Abboud, MD

    Recruiting

  • The Ohio State University

    Columbus, Ohio, 43210

    Mina Makary, MD

    Gage Spears, gage.spears@osumc.edu

    Recruiting

  • Univ Of Texas Southwestern

    Dallas, Texas, 75235

    Camille Harry, 214-648-8986, camille.harry@utsouthwestern.edu

    Sanjeeva Kalva, MD

    Recruiting

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

    Praneeth Nadimpalli, praneeth.v.nadimpalli@uth.tmc.edu

    Lauren McGuire, RN, lauren.c.mcguire@uth.tmc.edu

    Recruiting

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

    Victoria Mendoza, victoria-mendoza@uiowa.edu

    Michael Hummel, MD

    Recruiting

  • University of California, Irvine

    Irvine, California, 92627

    Nadine Jaoudeh, MD, nadine@hs.uci.edu

    Kimberly Padilla, kpadill6@hs.uci.edu

    Recruiting

  • University of California Los Angeles

    Los Angeles, California, 90095

    Renato Escobar, raescobar@mednet.ucla.edu

    Jessica Stewart, MD

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

    Celia Nunez, 615-322-4559, celia.m.nunez@vumc.org

    Anthony Borgmann, MD

    Recruiting

  • Yale New Haven

    New Haven, Connecticut, 06510

    Angelo Marino, MD, angelo.marino@yale.edu

    Patricia Fugal, patricia.fugal@yale.edu

    Recruiting

  • The Mount Sinai

    New York, New York, 10029

    Rajesh Patel, MD, rajesh.patel@mountsinai.org

    Aaron Greenberg, aaron.greenberg@mountsinai.org

    Recruiting

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07103

    Saharsh Patel, ssp186@gsbs.rutgers.edu

    Abhishek Kumar, MD

    Recruiting

  • CHI Health Creighton University Medical Center-Bergan-Mercy

    Omaha, Nebraska, 68124

    Janice Mitchel, 402-619-9402, jan.mitchell@commonspirit.org

    Patrick Harty

    Recruiting

  • Stanford Medical Center

    Palo Alto, California, 94304

    Andrew Picel, MD

    Abigail Bond, abond02@stanford.edu

    Recruiting

  • Mayo Clinic

    Phoenix, Arizona, 85054

    Debbie Ryan, 480-342-1208, ryan.debra29@mayo.edu

    Yahaira Parker

    Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15237

    Suzanne Burdin, burdins@upmc.edu

    Paula Novelli, MD

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Approximately 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.

Being tested
Onyx™ Liquid Embolic System
Keywords
Peripheral Arterial Hemorrhage, Embolization treatment
Medical subject headings
Wounds and Injuries, Gastrointestinal Hemorrhage, Ulcer, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Onyx™ Liquid Embolic SystemDevice

    Also called Embolization

    The proposed indication for Onyx™ LES is: Onyx™ LES is indicated for the embolization of arterial hemorrhage in the peripheral vasculature.

Study groups in NCT06742801
Study groupRoleWhat they receive
Treatment with Onyx LESExperimentalDevice; embolization with liquid embolic
Receives: Device: Onyx™ Liquid Embolic System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Through 30 days post-index procedure

  2. 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.

    Measured: Through 30 days post-index procedure

Secondary outcomes (4)

  1. Procedural Success

    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.

    Measured: At the completion of the index procedure

  2. Technical Success

    Technical Success is defined as absence of angiographic signs of bleeding after Onyx ™ embolization at each target location based on core lab assessment.

    Measured: At the completion of the index procedure

  3. Reintervention

    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.

    Measured: Through 30 days post-index procedure

  4. Transfusions

    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.

    Measured: Through 30 days post-index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2024
  2. Study start9 May 2025
  3. Primary completionApr 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
119 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06742801
Sponsor's protocol ID
MDT21044
Status last verified
Oct 2026
First submitted
11 Dec 2024
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Onyx™ Liquid Embolic System in people with Peripheral Arterial Hemorrhage and Trauma, run by Medtronic Endovascular at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Janki Shah (7322662503, janki.shah@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from Arterial Hemorrhage (time frame: Through 30 days post-index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06742801.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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