NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Onyx™ Liquid Embolic IDE Clinical Study

RecruitingNA

Sponsor: Medtronic Endovascular

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

Interventions: Onyx™ Liquid Embolic System

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 22 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (19)

Phoenix, Arizona, United States
Irvine, California, United States
Palo Alto, California, United States
Aurora, Colorado, United States
New Haven, Connecticut, United States
Chicago, Illinois, United States
Iowa City, Iowa, United States
Boston, Massachusetts, United States
Omaha, Nebraska, United States
Newark, New Jersey, United States
Albany, New York, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Pittsburgh, Pennsylvania, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States