An interventional study of Onyx™ Liquid Embolic System in Peripheral Arterial Hemorrhage, Trauma and GI Bleed, sponsored by Medtronic Endovascular. Recruiting at 20 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Medtronic Endovascular (part of Medtronic) · Not applicable, Interventional, and Treatment
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.
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.
Approximately 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.
2,217 studies on the registry are indexed under Wounds and Injuries; 441 are open to participants now.
This study's planned enrollment of 119 is above the median of 70 across 1,424 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Medtronic Endovascular is the lead sponsor of 51 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device; embolization with liquid embolic
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.
Also known as: Embolization
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 procedure
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 procedure
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 procedure
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 procedure
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 procedure
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 procedure
Ancillary Endpoint
Duration of the index procedure
Time frame: Through index procedure
Ancillary Endpoint
Length of hospitalization, post-index procedure
Time frame: Through 30 days post-index procedure
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 procedure
Plan to share: No
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for Apr 2027, 23 months after the start.
Of 53 industry-sponsored interventional studies with no phase under Wounds and Injuries, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 40. This study's planned 23 months is close to that.
Counting every sponsor, half of 599 studies reached it within 24 months; a quarter within 9 and three quarters within 48.
Wounds and Injuries covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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