RECRUITINGINTERVENTIONAL
Onyx™ Liquid Embolic IDE Clinical Study
PELE IDE Clinical Study, Peripheral Onyx™ Liquid Embolic Safety and Effectiveness of The Onyx™ LES for Embolization of Arterial Hemorrhage in the Peripheral Vasculature
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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.
Who Should NOT Join This Trial:
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DEVICE
Onyx™ Liquid Embolic System
The proposed indication for Onyx™ LES is: Onyx™ LES is indicated for the embolization of arterial hemorrhage in the peripheral vasculature.
Locations (14)
Mayo Clinic
Phoenix, Arizona, United States
University of California, Irvine
Irvine, California, United States
Stanford Medical Center
Palo Alto, California, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
Yale New Haven
New Haven, Connecticut, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Masschusetts General Hospital
Boston, Massachusetts, United States
CHI Health Creighton University Medical Center-Bergan-Mercy
Omaha, Nebraska, United States
Albany Medical Center
Albany, New York, United States
The Mount Sinai
New York, New York, United States
The Ohio State University
Columbus, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Univ Of Texas Southwestern
Dallas, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States