AXIOS Lumen Apposing Metal Stent for Walled Off Necrosis Drainage IDE Study

Boston Scientific

Status

Completed

Conditions

Walled Off Pancreatic Necrosis

Treatments

Device: AXIOS

Study type

Interventional

Funder types

Industry

Identifiers

NCT03525808

E7116

Details and patient eligibility

About

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%.

Full description

This study is a prospective, single arm, multi-center trial. Treatment of up to 40 patients will take place at up to 6 clinical centers. Patients who meet all eligibility criteria will receive the AXIOS stent for up to 60 days stent indwell and 6 months follow-up after stent removal.

Enrollment

40 patients

Sex

All

Ages

22 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age between 22 and 75 years old
Severe or moderately severe acute necrotizing pancreatitis, defined per the 2012 Revised Atlanta Classification.
WON resulting from necrotizing pancreatitis per contrast-enhanced CT with the following characteristics, per the 2012 Revised Atlanta Classification:
- Heterogeneous with liquid and non-liquid density with varying degrees of loculations (some may appear homogeneous)
- Well defined wall
- Location-intrapancreatic and/or extrapancreatic
Infected WON or symptomatic sterile WON Note: WON-related symptoms may include: pain, fever, leukocytosis, failure to thrive or deterioration of overall heath score, gastric outlet obstruction (GOO), weight loss, biliary obstructive symptoms, systemic inflammatory response syndrome (SIRS), deteriorating organ function, chronic nausea, lethargy, and inability to eat or gain weight
Imaging suggestive of greater than 30% necrotic material
WON ≥ 6cm in size
Eligible for endoscopic intervention
Acceptable candidate for endoscopic transluminal drainage
Patient understands the study requirements and the treatment procedures and provides written Informed Consent
Patient is willing to comply with all specified follow-up evaluations, including willingness to undergo a pre/post imaging study

Exclusion criteria

Pseudocyst
Cystic neoplasm
Untreated Pseudoaneurysm > 1cm within the WON
More than one WON clearly separated and requiring drainage
WONs that require dual modality interventions (endoscopic and percutaneous) from the beginning (i.e. deep paracolic space involvement that is inaccessible through the central drainage access)
Prior surgical, interventional radiology or endoscopic procedures for the treatment of the WON
Abnormal coagulation:
- INR > 1.5 and not correctable
- presence of a bleeding disorder
- platelets < 50,000/mm3
Intervening gastric varices or unavoidable blood vessels within the access tract (visible using endoscopy or endoscopic ultrasound)
WON that poorly approximates the GI lumen (≥1cm away)
Pericolic gutter necrosis
Pelvic necrosis
Prior true anaphylactic reaction to contrast agents, nitinol (nickel titanium), silicone or any other materials contacting the patient
Female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study
Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study