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Treatment of Peripheral Arterial Hemorrhage With Lava LES (The LAVA Study)
NA trial testing Liquid Embolic in Peripheral Arterial Hemorrhage in 113 participants. Completed in 17 August 2022.
| Lead sponsor | BlackSwan Vascular, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 113 |
| Start date | 14 April 2021 |
| Primary completion | 17 August 2022 |
| Estimated completion | 17 August 2022 |
| Sites | 9 locations across United States |
BlackSwan Vascular, Inc.
18 and older, any sex, with Peripheral Arterial Hemorrhage. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Lava LES | 100 | 96.4 – 100 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Lava LES | 94.3 | 89.1 – 97.5 |
Time frame: Up to 6 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Lava LES |
|---|---|---|
| Sepsis | Infections and infestations | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Death | General disorders | — |
| Extravasation blood | Vascular disorders | — |
| Atrial fibrillation | Cardiac disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Melaena | Gastrointestinal disorders | — |
| Flank pain | General disorders | — |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | — |
| Chronic myeloid leukaemia | Blood and lymphatic system disorders | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — |
| Cardiac arrest | Cardiac disorders | — |
| Chest pain | Cardiac disorders | — |
| Haematochezia | Gastrointestinal disorders | — |
| Ileus | Gastrointestinal disorders | — |
| Small intestinal perforation | Gastrointestinal disorders | — |
| Cholangitis infective | Hepatobiliary disorders | — |
| Gallbladder rupture | Hepatobiliary disorders | — |
| Acute respiratory failure | Metabolism and nutrition disorders | — |
| Respiratory failure | Metabolism and nutrition disorders | — |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Acute kidney injury | Renal and urinary disorders | — |
| Nephrolithiasis | Renal and urinary disorders | — |
| COVID-19 | Respiratory, thoracic and mediastinal disorders | — |
| Reaction | System | Lava LES |
|---|---|---|
| Abdominal pain | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Tachycardia | Cardiac disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Pyrexia | General disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Arthralgia | Investigations | — |
| Hypertension | Vascular disorders | — |
| Ascites | Cardiac disorders | — |
| Abdominal pain lower | Gastrointestinal disorders | — |
| Bacteraemia | Infections and infestations | — |
| Back pain | Investigations | — |
| Urinary tract infection | Renal and urinary disorders | — |
| Vaginal haemorrhage | Reproductive system and breast disorders | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | — |
| Deep vein thrombosis | Vascular disorders | — |
| Blood loss anaemia | Blood and lymphatic system disorders | — |
| Thrombocytosis | Blood and lymphatic system disorders | — |
| Dizziness | Cardiac disorders | — |
| Deafness unilateral | Ear and labyrinth disorders | — |
| Hypoglycaemia | Endocrine disorders | — |
| Abdominal discomfort | Gastrointestinal disorders | — |
| Abdominal distension | Gastrointestinal disorders | — |
| Abdominal pain upper | Gastrointestinal disorders | — |
| Colitis | Gastrointestinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Duodenitis | Gastrointestinal disorders | — |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | — |
| Omental haemorrhage | Gastrointestinal disorders | — |
| Pancreatic pseudocyst | Gastrointestinal disorders | — |
| Cachexia | General disorders | — |
| Oedema | General disorders | — |
| Peripheral swelling | General disorders | — |
| Bile duct stenosis | Hepatobiliary disorders | — |
| Cholelithiasis | Hepatobiliary disorders | — |
| Haemangioma of liver | Hepatobiliary disorders | — |
| Infusion related reaction | Immune system disorders | — |
| Clostridium difficile colitis | Infections and infestations | — |
| Clostridium difficile infection | Infections and infestations | — |
Most-reported serious reactions: Sepsis, Anaemia, Death, Extravasation blood, Atrial fibrillation, Abdominal pain, Melaena, Flank pain.
Data from ClinicalTrials.gov NCT04649255 adverse events section.
To evaluate the safety and effectiveness of the Lava LES for the embolic treatment of arterial hemorrhage in the peripheral vasculature.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing