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

NCT03525808 | Completed Results FDA Device

• 1 other identifier: E7116
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

Brief Summary

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%.

Conditions

Walled Off Pancreatic Necrosis

Keywords

Pancreatic necrosis

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Resolution of WON With Endoscopic Drainage

  Resolution of WON with endoscopic drainage defined as radiographic decrease of WON size to ≤ 3cm evaluated by CT scan or MRI

  Up to 60 Days

• AXIOS Stent Related or WON Drainage Procedure Related Serious Adverse Events

  AXIOS stent related or WON drainage procedure related serious adverse events

  Through study completion, average of 8 months

Secondary Outcomes (10)

• Symptom Reduction

  Through study completion, average of 8 months

• Technical Success

  Intraoperative (Stent placement)

• Drainage Procedural Time

  Intraoperative (Stent placement)

• Resolution of WON: Radiographic Resolution Evaluated by MRI or CT

  Through study completion, average of 8 months

• Time to WON Resolution

  Up to 60 Days

Study Arms (1)

AXIOS

EXPERIMENTAL

Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis.

Device: AXIOS

Interventions

AXIOS DEVICE

Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.

AXIOS

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (5)

University of Colorado, Denver

Aurora, Colorado, 80045, United States

Location

Emory University Healthcare

Atlanta, Georgia, 30322, United States

Location

Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Dayyeh BKA, Chandrasekhara V, Shah RJ, Easler JJ, Storm AC, Topazian M, Levy MJ, Martin JA, Petersen BT, Takahashi N, Edmundowicz S, Hammad H, Wagh MS, Wani S, DeWitt J, Bick B, Gromski M, Al Haddad M, Sherman S, Merchant AA, Peetermans JA, Gjata O, McMullen E, Willingham FF. Combined Drainage and Protocolized Necrosectomy Through a Coaxial Lumen-apposing Metal Stent for Pancreatic Walled-off Necrosis: A Prospective Multicenter Trial. Ann Surg. 2023 May 1;277(5):e1072-e1080. doi: 10.1097/SLA.0000000000005274. Epub 2023 Apr 6.

  PMID: 35129503 DERIVED

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases

Results Point of Contact

• Title: Ornela Gjata
• Organization: Boston Scientific

Ornela.Gjata@bsci.com

(508)-683-4155

Study Officials

• Barham K Abu Dayyeh, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: May 16, 2018
• Study Start: September 5, 2018
• Primary Completion: March 31, 2020
• Study Completion: October 2, 2020
• Last Updated: December 20, 2021
• Results First Posted: December 20, 2021

Record last verified: 2021-12

Locations

US (5)