Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
119 participants
INTERVENTIONAL
2025-05-09
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Predicting the Safety and Effectiveness of Inferior Vena Cava Filters
NCT02381509
Tunneled Peripherally Inserted Central Catheter (PICC) in Adult Patients and Associated Outcomes
NCT06365528
Intra-Osseous Access in Difficult Vascular Access Cases
NCT05708833
Safe-Infusion Study
NCT06727240
RexMedical- Option* Vena Cava Filter IDE Study
NCT00488865
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment with Onyx LES
Device; embolization with liquid embolic
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
22 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medtronic Endovascular
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Osman Ahmed, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Univ Of Texas Southwestern
Dallas, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Xavier Lopez
Role: backup
Andrew Picel, MD
Role: primary
Meredith Durbahn
Role: backup
Judith Pena Quevedo, AGNP-C, CCRC
Role: primary
Mina Makary, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MDT21044
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.