Onyx™ Liquid Embolic IDE Clinical Study

About

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 3

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

22 Years

Maximum Age

N/A

Inclusion Criteria:

Patient is ≥ 22 years old.
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.
Patient or legally authorized representative (LAR) is able to provide written consent to participate in the study.
Life expectancy of >30 days, in the opinion of the investigator at the time of enrollment.
Target treatment area is free from prior embolization treatment.

Exclusion Criteria:

Pregnant or breastfeeding.
Symptoms of active infection.
Patient is known to be participating in the study of an investigational drug, biologic, or device.
Contrast allergy or other contraindication to angiography, CT, or catheterization, including contrast sensitivity that cannot be adequately treated prior to index procedure.
Known allergy to components of Onyx™.
Target vasculature unsuitable for the delivery of Onyx™ based upon physician assessment.
More than 4 target lesions will require embolization, in the investigator's opinion after imaging-based assessment.