Treatment of Peripheral Arterial Hemorrhage With Lava LES (The LAVA Study) (NCT04649255) | Clinical Trial Compass
CompletedNot Applicable
Treatment of Peripheral Arterial Hemorrhage With Lava LES (The LAVA Study)
United States113 participantsStarted 2021-04-14
Plain-language summary
To evaluate the safety and effectiveness of the Lava LES for the embolic treatment of arterial hemorrhage in the peripheral vasculature.
Who can participate
Age range18 Years
SexALL
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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 diagn…
What they're measuring
1
Percentage of Participants With Composite of Freedom From Major Adverse Events (MAEs)