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AXIOS Lumen Apposing Metal Stent for Walled Off Necrosis Drainage IDE Study
NA trial testing AXIOS in Walled Off Pancreatic Necrosis in 40 participants. Completed in 2 October 2020.
| Lead sponsor | Boston Scientific Corporation |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 5 September 2018 |
| Primary completion | 31 March 2020 |
| Estimated completion | 2 October 2020 |
| Sites | 5 locations across United States |
Boston Scientific Corporation — full company profile →
Adults 22 to 75, any sex, with Walled Off Pancreatic Necrosis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Resolution of WON with endoscopic drainage defined as radiographic decrease of WON size to ≤ 3cm evaluated by CT scan or MRI
| Group | Value | 95% CI |
|---|---|---|
| AXIOS | 39 |
AXIOS stent related or WON drainage procedure related serious adverse events
| Group | Value | 95% CI |
|---|---|---|
| AXIOS | 3 |
Reduction of WON-related clinical symptoms. Note: WON-related symptoms as defined in Inclusion Criteria #4
| Group | Value | 95% CI |
|---|---|---|
| AXIOS | 29 |
Technical AXIOS stent placement success, defined as placement in desired location using endoscopic/EUS techniques per standard of practice. Technical AXIOS stent removal success, defined as ability to remove the AXIOS stent using an endoscopic snare or forceps or graspers without AXIOS stent removal related serious adverse events.
| Group | Value | 95% CI |
|---|---|---|
| AXIOS | 40 |
| Group | Value | 95% CI |
|---|---|---|
| AXIOS | 40 |
Time elapsed between initial puncture of the WON with electrocautery to endoscope retrieval.
| Group | Value | 95% CI |
|---|---|---|
| AXIOS | 22.6 | ± 11.3 |
Resolution of WON with or without necrosectomy by 6 months post AXIOS stent removal.
| Group | Value | 95% CI |
|---|---|---|
| AXIOS | 40 |
Time to WON resolution using same definition as for primary endpoint, namely: * Resolution of WON with endoscopic drainage defined as radiographic decrease of WON size to ≤ 3cm evaluated by CT scan or MRI.
| Group | Value | 95% CI |
|---|---|---|
| AXIOS | 34.1 | ± 16.8 |
Recurrence of WON after initial resolution and up to 6 months post AXIOS stent removal.
| Group | Value | 95% CI |
|---|---|---|
| AXIOS | 0 |
Stent lumen patency, evaluated via imaging or direct visual inspection with endoscope, and defined as one or both of the following: * Drainage through AXIOS stent visualized from the stomach or bowel, and/or * Visual confirmation of AXIOS stent lumen patency
| Group | Value | 95% CI |
|---|---|---|
| AXIOS | 40 |
Fluoroscopy (time) per endoscopic procedure.
| Group | Value | 95% CI |
|---|---|---|
| AXIOS | 4.6 | ± 6.1 |
Number of participants with new organ failure from drainage procedure to WON resolution.
| Group | Value | 95% CI |
|---|---|---|
| AXIOS | 1 |
\*Change\* in Quality of Life score (SF-12 questionnaire) from \*baseline to stent removal\*. The SF-12 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning
| Group | Value | 95% CI |
|---|---|---|
| AXIOS | 23.6 | ± 20.5 |
Time frame: From stent implant to 6-month post-stent removal. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | AXIOS |
|---|---|---|
| Sepsis | Infections and infestations | — |
| Pancreatitis | Gastrointestinal disorders | — |
| Pancreatitis acute | Gastrointestinal disorders | — |
| Complication associated with device | General disorders | — |
| Abdominal pain upper | Gastrointestinal disorders | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — |
| Bacteraemia | Infections and infestations | — |
| Extravasation | General disorders | — |
| Shock | Vascular disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Cholecystitis acute | Hepatobiliary disorders | — |
| Gastrointestinal infection | Infections and infestations | — |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | — |
| Chest pain | General disorders | — |
| Monoplegia | Nervous system disorders | — |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | — |
| Acute kidney injury | Renal and urinary disorders | — |
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | — |
| Malnutrition | Metabolism and nutrition disorders | — |
| Cardiac arrest | Cardiac disorders | — |
| Hyperparathyroidism | Endocrine disorders | — |
| Pneumatosis intestinalis | Gastrointestinal disorders | — |
| Pancreatic leak | Injury, poisoning and procedural complications | — |
| Reaction | System | AXIOS |
|---|---|---|
| Localised infection | Infections and infestations | — |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | — |
Most-reported serious reactions: Sepsis, Pancreatitis, Pancreatitis acute, Complication associated with device, Abdominal pain upper, Hypoxia, Bacteraemia, Extravasation.
Data from ClinicalTrials.gov NCT03525808 adverse events section.
To demonstrate safety and effectiveness of lumen-apposing metal stents for resolution of walled off pancreatic necrosis (WONs) in patients with WONs with solid component \>30%.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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