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Onyx™ Liquid Embolic IDE Clinical Study

Medtronic Endovascular · NCT06742801

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 22+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
119
US sites recruiting
20
Study start
May 9, 2025
Record last updated
October 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Onyx™ Liquid Embolic System

Conditions: Peripheral Arterial Hemorrhage; Trauma; GI Bleed; Ulcer; Hemorrhage

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Recruiting US locations

  • Mayo Clinic

    Phoenix, AZ 85054

    Site contact: Debbie Ryan · 480-342-1208 · ryan.debra29@mayo.edu

  • University of California, Irvine

    Irvine, CA 92627

    Site contact: Nadine Jaoudeh, MD · nadine@hs.uci.edu

  • University of California Los Angeles

    Los Angeles, CA 90095

    Site contact: Renato Escobar · raescobar@mednet.ucla.edu

  • Stanford Medical Center

    Palo Alto, CA 94304

    Site contact: Andrew Picel, MD

  • UCHealth University of Colorado Hospital

    Aurora, CO 80045

    Site contact: Alejandra Aguilar, MPH · alejandra.aguilar@cuanschutz.edu

  • Yale New Haven

    New Haven, CT 06510

    Site contact: Angelo Marino, MD · angelo.marino@yale.edu

  • University of Chicago

    Chicago, IL 60637

    Site contact: Tiana Jackson · tiana.jackson@bsd.uchicago.edu

  • University of Iowa Hospitals and Clinics

    Iowa City, IA 52242

    Site contact: Victoria Mendoza · victoria-mendoza@uiowa.edu

  • Masschusetts General Hospital

    Boston, MA 02114

    Site contact: Vincent Wu, MD · vwu3@mgh.harvard.edu

  • CHI Health Creighton University Medical Center-Bergan-Mercy

    Omaha, NE 68124

    Site contact: Janice Mitchel · 402-619-9402 · jan.mitchell@commonspirit.org

  • Rutgers New Jersey Medical School

    Newark, NJ 07103

    Site contact: Saharsh Patel · ssp186@gsbs.rutgers.edu

  • Albany Medical Center

    Albany, NY 12208

    Site contact: Gary Siskin, MD · sisking@amc.edu

  • The Mount Sinai

    New York, NY 10029

    Site contact: Rajesh Patel, MD · rajesh.patel@mountsinai.org

  • University of North Carolina at Chapel Hill

    Chapel Hill, NC 27599

    Site contact: Adriana Delgado · adriana_delgado@med.unc.edu

  • University Hospitals Cleveland Medical Center

    Cleveland, OH 44106

    Site contact: Lauren Hahn · lauren.hahn@uhhospitals.org

  • The Ohio State University

    Columbus, OH 43210

    Site contact: Mina Makary, MD

  • University of Pittsburgh Medical Center

    Pittsburgh, PA 15237

    Site contact: Suzanne Burdin · burdins@upmc.edu

  • Vanderbilt University Medical Center

    Nashville, TN 37212

    Site contact: Celia Nunez · 615-322-4559 · celia.m.nunez@vumc.org

  • Univ Of Texas Southwestern

    Dallas, TX 75235

    Site contact: Camille Harry · 214-648-8986 · camille.harry@utsouthwestern.edu

  • The University of Texas Health Science Center at Houston

    Houston, TX 77030

    Site contact: Praneeth Nadimpalli · praneeth.v.nadimpalli@uth.tmc.edu

Study contacts (from the official record)

  • Janki Shah · 7322662503 · janki.shah@medtronic.com
  • Liza Marie · 7072172314 · liza.marie@medtronic.com
Onyx™ Liquid Embolic IDE Clinical Study (NCT06742801) | Bored Studies