Onyx™ Liquid Embolic IDE Clinical Study
Purpose
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.
Conditions
- Peripheral Arterial Hemorrhage
- Trauma
- GI Bleed
- Ulcer
- Hemorrhage
Eligibility
- Eligible Ages
- Over 22 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment with Onyx LES |
Device; embolization with liquid embolic |
|
Recruiting Locations
Phoenix 5308655, Arizona 5551752 85054
Irvine 5359777, California 5332921 92627
Palo Alto 5380748, California 5332921 94304
Andrew Picel, MD
Aurora 5412347, Colorado 5417618 80045
New Haven 4839366, Connecticut 4831725 06510
Iowa City 4862034, Iowa 4862182 52242
Judith Pena Quevedo, AGNP-C, CCRC
Omaha 5074472, Nebraska 5073708 68124
Albany 5106834, New York 5128638 12208
New York 5128581, New York 5128638 10029
Columbus 4509177, Ohio 5165418 43210
Mina Makary, MD
Dallas 4684888, Texas 4736286 75235
Houston 4699066, Texas 4736286 77030
More Details
- Status
- Recruiting
- Sponsor
- Medtronic Endovascular
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.