Onyx™ Liquid Embolic IDE Clinical Study

Not Applicable

Recruiting

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

• Registration Number: NCT06742801
• Lead Sponsor: Medtronic Endovascular

Brief 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.

Study Timeline

• Study First Submitted: 2024-12-11
• Study First Submitted QC: 2024-12-18
• Study First Posted: 2024-12-19
• Status Verified: 2025-05
• Study Start: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2026-11
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 119

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Freedom from Arterial Hemorrhage	Through 30 days post-index procedure	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.
Freedom from System-related Major Adverse Events (MAE)	Through 30 days post-index procedure	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.

Secondary Outcome Measures

Name	Time	Method
Procedural Success	At the completion of the index procedure	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.
Technical Success	At the completion of the index procedure	Technical Success is defined as absence of angiographic signs of bleeding after Onyx ™ embolization at each target location based on core lab assessment.
Reintervention	Through 30 days post-index procedure	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.
Transfusions	Through 30 days post-index procedure	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.

Trial Locations

Locations (1)

UCHealth University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States