Onyx™ Liquid Embolic IDE Clinical Study

Medtronic

Status: Not yet enrolling

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

Treatments: Device: Onyx™ Liquid Embolic System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06742801

MDT21044

Details and patient eligibility

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.

Full 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.

Enrollment: 119 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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119 participants in 1 patient group

Treatment with Onyx LES

Experimental group

Description:

Device; embolization with liquid embolic

Treatment:

Device: Onyx™ Liquid Embolic System