GI Bleed, Hemorrhage, Peripheral Arterial Hemorrhage, Trauma, Ulcer
Conditions
Keywords
Peripheral Arterial Hemorrhage, Embolization 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.
Interventions
DEVICEOnyx™ Liquid Embolic System
The proposed indication for Onyx™ LES is: Onyx™ LES is indicated for the embolization of arterial hemorrhage in the peripheral vasculature.
Sponsors
Medtronic Endovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from Arterial Hemorrhage | Through 30 days post-index procedure | Freedom from arterial hemorrhage in all target location(s) after treatment with Onyx™ LES at the index procedure without re-embolization or any other intervention at the target location(s) due to persistent or recurrent hemorrhage through 30 days. Freedom from arterial hemorrhage where an arterial hemorrhage event is defined as a type 3 or greater BARC bleeding criteria as assessed by the Clinical Events Committee (CEC) through 30 days. |
| Freedom from System-related Major Adverse Events (MAE) | Through 30 days post-index procedure | The primary safety endpoint is defined as freedom from system-related Major Adverse Events (MAE) through 30 days after the point of enrollment as assessed by the CEC. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Success | At the completion of the index procedure | successful delivery and deployment of Onyx™ to the target location without non-target embolization or Onyx™ cast migration and the successful removal of the delivery system at the completion of the index procedure. |
| Technical Success | At the completion of the index procedure | Technical Success is defined as absence of angiographic signs of bleeding after Onyx ™ embolization at each target location based on core lab assessment. |
| Reintervention | Through 30 days post-index procedure | Reintervention is defined as the number of additional procedures needed to treat the target location(s) embolized with Onyx™ through 30 days following the index procedure. |
| Transfusions | Through 30 days post-index procedure | Transfusions defined as the number of blood transfusions required post-index procedure through 30 days will use blood transfusions starting after the removal of the delivery system. The number of blood units used for each transfusion will also be collected. |
Countries
United States
Contacts
CONTACTJanki Shah
CONTACTLiza Marie
PRINCIPAL_INVESTIGATOROsman Ahmed, MD
University of Chicago
Outcome results
None listed