NCT06742801

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 119 (estimated)
• Sponsor: Medtronic Endovascular · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Arterial Hemorrhage
• Trauma
• GI Bleed
• Ulcer
• Hemorrhage

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-09
• Primary completion: 2026-11-01
• Completion: 2026-12-01
• First posted: 2024-12-19
• Last updated: 2026-03-05

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated device study