Clinical trial NCT06742801: Onyx™ Liquid Embolic IDE Clinical Study
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Arterial Hemorrhage
Trauma
GI Bleed
Ulcer
Hemorrhage
Keywords: Peripheral Arterial Hemorrhage
Embolization treatment
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2024-12-19
Enrollment: 119
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Freedom from Arterial Hemorrhage
timeFrame: Through 30 days post-index procedure
measure: Freedom from System-related Major Adverse Events (MAE)
timeFrame: Through 30 days post-index procedure
Secondary outcomes:
measure: Procedural Success
timeFrame: At the completion of the index procedure
measure: Technical Success
timeFrame: At the completion of the index procedure
measure: Reintervention
timeFrame: Through 30 days post-index procedure
measure: Transfusions
timeFrame: Through 30 days post-index procedure
Other outcomes:
measure: Ancillary Endpoint
timeFrame: Through index procedure
measure: Ancillary Endpoint
timeFrame: Through 30 days post-index procedure
measure: Ancillary Endpoint
timeFrame: Through 30 days post-index procedure
Locations:
city: Palo Alto
country: United States
facility: Stanford Medical Center
state: California
city: Aurora
country: United States
facility: UCHealth University of Colorado Hospital
state: Colorado
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: University of Chicago
name: Osman Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
References: