Clinical trial NCT04649255: Treatment of Peripheral Arterial Hemorrhage With Lava LES (The LAVA Study)
Official title: Liquid Embolization of Arterial Hemorrhages in the Peripheral Vasculature: The LAVA Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Hemorrhage
Keywords: Peripheral Arterial Hemorrhage
Embolic Treatment
Lead sponsor: BlackSwan Vascular, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Syntactx
First posted: 2020-12-02
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and effectiveness of the Lava LES for the embolic treatment of arterial hemorrhage in the peripheral vasculature.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Composite of Freedom From Major Adverse Events (MAEs)
timeFrame: 30 Days
measure: Percentage of Lesions to Achieve Clinical Success
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Albany
country: United States
facility: Albany University Medical Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: Rush University Medical Center
name: Bulent Arslan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Joseph Heart and Vascular Center
name: Mahmood Razavi, MD
role: PRINCIPAL_INVESTIGATOR
References: