Treatment of Peripheral Arterial Hemorrhage With Lava LES (The LAVA Study)
Completed · Not applicable
Conditions studied: Peripheral Arterial Hemorrhage
In brief
To evaluate the safety and effectiveness of the Lava LES for the embolic treatment of arterial hemorrhage in the peripheral vasculature.
Key facts
- Study ID
- NCT04649255
- Run by
- BlackSwan Vascular, Inc.
- People needed
- 113
- Starts
- 2021-04-14
- Expected to finish
- 2022-08-17
- Last updated by the study team
- 2024-04-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of California — Irvine, California, United States
- University of Southern California — Los Angeles, California, United States
- University of Miami — Miami, Florida, United States
- Rush University Medical Center — Chicago, Illinois, United States
- Indiana University — Indianapolis, Indiana, United States
- University of Maryland — Baltimore, Maryland, United States
- Albany University Medical Center — Albany, New York, United States
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
- University of North Carolina — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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