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RECRUITING
NCT06742801
NA

Onyx™ Liquid Embolic IDE Clinical Study

Sponsor: Medtronic Endovascular

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

119

Start Date

2025-05-09

Completion Date

2026-12

Last Updated

2026-03-05

Healthy Volunteers

No

Interventions

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.

Locations (14)

Mayo Clinic

Phoenix, Arizona, United States

University of California, Irvine

Irvine, California, United States

Stanford Medical Center

Palo Alto, California, United States

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Yale New Haven

New Haven, Connecticut, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Masschusetts General Hospital

Boston, Massachusetts, United States

CHI Health Creighton University Medical Center-Bergan-Mercy

Omaha, Nebraska, United States

Albany Medical Center

Albany, New York, United States

The Mount Sinai

New York, New York, United States

The Ohio State University

Columbus, Ohio, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Univ Of Texas Southwestern

Dallas, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States