Peripheral Arterial Hemorrhage
Conditions
Keywords
Peripheral Arterial Hemorrhage, Embolic Treatment
Brief summary
To evaluate the safety and effectiveness of the Lava LES for the embolic treatment of arterial hemorrhage in the peripheral vasculature.
Interventions
DEVICELiquid Embolic
Lava Liquid Embolic System (LES)
Sponsors
Syntactx
BlackSwan Vascular, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Subject screening commenced on April 14, 2021 with the first subject enrolled on April 14, 2021. 160 subjects were screened at 20 investigational sites in the United States of America with no more than 25 subjects enrolled at any single site. 113 subjects were enrolled (successful arterial access established to the target lesion) at 19 sites in the Intent to treat (ITT) population.
Participants by arm
| Arm | Count |
|---|---|
| Lava LES Liquid Embolic: Lava Liquid Embolic System (LES) | 113 |
| Total | 113 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 9 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Lava LES |
|---|---|
| Age, Continuous | 57.4 years |
| Body Mass Index (BMI) | 28.9 kg/m^2 STANDARD_DEVIATION 6.88 |
| Currently Taking Anticoagulant Agents | 8 Participants |
| Currently Taking Antiplatelet Agents | 9 Participants |
| Etiology of Bleeding Benign Neoplasm | 1 Participants |
| Etiology of Bleeding Congenital Vascular Lesion | 0 Participants |
| Etiology of Bleeding Iatrogenic | 29 Participants |
| Etiology of Bleeding Malignant Neoplasm | 5 Participants |
| Etiology of Bleeding Mallory Weiss Tear | 0 Participants |
| Etiology of Bleeding Other (Not otherwise specified) | 35 Participants |
| Etiology of Bleeding Traumatic, non-iatrogenic | 32 Participants |
| Etiology of Bleeding Ulcer | 5 Participants |
| Etiology of Bleeding Unknown | 6 Participants |
| Race/Ethnicity, Customized Asian | 10 Participants |
| Race/Ethnicity, Customized Black or African-American | 16 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Other (Not otherwise specified) | 18 Participants |
| Race/Ethnicity, Customized White | 63 Participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 72 Participants |
| Target Bleed Territory - Upper GI Extremity | 8 Participants |
| Target Bleed Territory - Upper GI Lower GI | 10 Participants |
| Target Bleed Territory - Upper GI Non-GI Visceral | 41 Participants |
| Target Bleed Territory - Upper GI Other (Not otherwise specified) | 43 Participants |
| Target Bleed Territory - Upper GI Upper GI | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 9 / 113 |
| other Total, other adverse events | 92 / 113 |
| serious Total, serious adverse events | 49 / 113 |
Outcome results
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.
Time frame: 30 days
Population: Analysis based on the intent-to-treat (ITT) population with valid assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lava LES | Percentage of Lesions to Achieve Clinical Success | 94.3 percentage of lesions |
Comparison: Descriptive assessment; H0: PE ≤ PGE, versus HA: PE \> PGE, where PE is the proportion of target lesions with clinical success and PGE is the effectiveness performance goal of 72%.p-value: <0.02595% CI: [89.1, 97.5]One-sided exact binomial test
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.
Time frame: 30 Days
Population: Analysis based on the intent-to-treat (ITT) population with valid assessment. The baseline number of subjects was 113 but only 101 subjects were administered the assigned intervention (Lava LES), thus 101 subjects were evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lava LES | Percentage of Participants With Composite of Freedom From Major Adverse Events (MAEs) | 100 percentage of participants |
Comparison: Descriptive assessment; H0: Ps ≤ PGS, versus HA: PS \> PGS, where where Ps is the population primary safety success rate in the Test group and PGS is the safety performance goal of 82%.p-value: <0.02595% CI: [96.4, 100]One-sided exact binomial test