Treatment of Peripheral Arterial Hemorrhage With Lava LES (The LAVA Study)

Not Applicable

Completed

• Conditions: Peripheral Arterial Hemorrhage
• Interventions: Device: Liquid Embolic

• Registration Number: NCT04649255
• Lead Sponsor: BlackSwan Vascular, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-23
• Study First Submitted QC: 2020-11-30
• Study First Posted: 2020-12-02
• Study Start: 2021-04-14
• Primary Completion: 2022-08-17
• Study Completion: 2022-08-17
• Results First Submitted: 2023-08-17
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-08
• Last Update Submitted: 2024-04-08
• Results First Posted: 2024-04-12
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lava LES	Liquid Embolic	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Composite of Freedom From Major Adverse Events (MAEs)	30 Days	A composite of freedom from 30-day MAEs include ischemia or infarction of the target territory, non-target embolization, allergic reactions to Lava, catheter breakage, and catheter entrapment defined as the inability to withdraw a catheter from adherence to Lava.
Percentage of Lesions to Achieve Clinical Success	30 days	Defined as absence of bleeding from the target lesion after embolization with the Lava LES, without the need for emergency surgery, re-embolization, or other target lesion reinterventions.

Trial Locations

Locations (9)

University of Southern California; 🇺🇸 Los Angeles, California, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

University of California; 🇺🇸 Irvine, California, 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 Miami; 🇺🇸 Miami, Florida, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States