Treatment of Peripheral Arterial Hemorrhage With Lava LES (The LAVA Study)
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-003717
NCT ID: NCT04649255
Sponsor Protocol Number: TPR-00913-01.A
About this study
The purpose of this study is to evaluate the safety and effectiveness of the Lava LES for the embolic treatment of arterial hemorrhage in the peripheral vasculature.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age ≥ 18 years.
- Active arterial bleeding in the peripheral vasculature, documented on a suitable imaging study.
- Subject or subject's legally authorized representative is able and authorized to provide written informed consent for the procedure and the study.
- Subject is willing and able to comply with the specified follow-up evaluation schedule.
- Life expectancy > 30 days.
- No prior embolization in the target territory.
Exclusion Criteria:
- Pregnancy or breast feeding. A woman who, in the Investigator's opinion, is of child-bearing potential must have a negative pregnancy test within 7 days before the index procedure.
- Coexisting signs of peritonitis or other active infection.
- Participation in an investigational study of a new drug, biologic or device that has not reached its primary endpoint at the time of study screening.
- Uncorrectable coagulopathies such as thrombocytopenia < 40,000/ μL, international normalization ratio (INR) > 2.0.
- Contraindication to angiography or catheterization, including untreatable allergy to iodinated contrast media.
- Anatomic arterial unsuitability such that, in the Investigator's opinion, the delivery catheter cannot gain access to the selected position for safe and intended embolization.
- Known allergy or other contraindication to any components of Lava LES including dimethyl sulfoxide (DMSO).
- More than 4 Target Lesions will require embolization, in the Investigator's opinion after performance of diagnostic angiography or another suitable imaging study.
Eligibility last updated 8/25/21. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Emily Bendel, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available