Peripheral Arterial Hemorrhage Clinical Trial
Official title:
Liquid Embolization of Arterial Hemorrhages in the Peripheral Vasculature: The LAVA Study
| Verified date | April 2024 |
| Source | BlackSwan Vascular, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To evaluate the safety and effectiveness of the Lava LES for the embolic treatment of arterial hemorrhage in the peripheral vasculature.
| Status | Completed |
| Enrollment | 113 |
| Est. completion date | August 17, 2022 |
| Est. primary completion date | August 17, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Albany University Medical Center | Albany | New York |
| United States | University of Maryland | Baltimore | Maryland |
| United States | University of North Carolina | Chapel Hill | North Carolina |
| United States | Rush University Medical Center | Chicago | Illinois |
| United States | Indiana University | Indianapolis | Indiana |
| United States | University of California | Irvine | California |
| United States | University of Southern California | Los Angeles | California |
| United States | University of Miami | Miami | Florida |
| United States | Icahn School of Medicine at Mount Sinai | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| BlackSwan Vascular, Inc. | Syntactx |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With Composite of Freedom From Major Adverse Events (MAEs) | 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. | 30 Days | |
| Primary | Percentage of Lesions to Achieve Clinical Success | 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. | 30 days |