Onyx™ Liquid Embolic IDE Clinical Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorMedtronic Endovascular
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient is ≥ 22 years old.
Active arterial bleeding in the peripheral vasculature confirmed by radiologic and/or endoscopic imaging and deemed suitable for embolization treatment by the investigator.
Patient or legally authorized representative (LAR) is able to provide written consent to participate in the study.
Life expectancy of >30 days, in the opinion of the investigator at the time of enrollment.
Disqualifiers
Pregnant or breastfeeding.
Symptoms of active infection.
Patient is known to be participating in the study of an investigational drug, biologic, or device.
Contrast allergy or other contraindication to angiography, CT, or catheterization, including contrast sensitivity that cannot be adequately treated prior to index procedure.
Trial design
Design model
Single group
Treatments tested in this trial
Onyx™ Liquid Embolic System
DeviceThe proposed indication for Onyx™ LES is: Onyx™ LES is indicated for the embolization of arterial hemorrhage in the peripheral vasculature.
Treatment groups
119 Participants
are divided into 1 treatment groupGroup A: Treatment with Onyx LESExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Freedom from Arterial Hemorrhage
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.
Time frame
Through 30 days post-index procedure2
Freedom from System-related Major Adverse Events (MAE)
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.
Time frame
Through 30 days post-index procedureSecondary outcomes
1
Procedural Success
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.
Time frame
At the completion of the index procedure2
Technical Success
Technical Success is defined as absence of angiographic signs of bleeding after Onyx ™ embolization at each target location based on core lab assessment.
Time frame
At the completion of the index procedure3
Reintervention
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.
Time frame
Through 30 days post-index procedure4
Transfusions
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.
Time frame
Through 30 days post-index procedureOther outcomes
1
Ancillary Endpoint
Duration of the index procedure
Time frame
Through index procedure2
Ancillary Endpoint
Length of hospitalization, post-index procedure
Time frame
Through 30 days post-index procedure3
Ancillary Endpoint
Tabulate adjunctive use of other types of embolic agents to treat target locations at index procedure and reinterventions
Time frame
Through 30 days post-index procedureSponsors and contacts
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Source ClinicalTrials.gov