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NCT06742801NARecruiting

Onyx™ Liquid Embolic IDE Clinical Study

Medtronic Endovascular

Start Date

5/9/2025

Completion Date

5/1/2027

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.

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.

Eligibility Criteria

Age Range: 22 years to No maximum

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.

Interventions

DEVICE

Onyx™ Liquid Embolic System

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Conditions

Peripheral Arterial HemorrhageTraumaGI BleedUlcerHemorrhage

Locations

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

Rutgers New Jersey Medical School

Newark, New Jersey 07103

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

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania 15237

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