AXIOS™ for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE
AXIOS™ for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE
To evaluate the safety and effectiveness of the AXIOS™ Stent with Electrocautery Enhanced
 Delivery System in the management of symptoms of acute cholecystitis as an alternative to
 percutaneous gallbladder drainage.
This study is a prospective, single arm, multi center trial. Treatment of up to 30 patients
 will take place at up to 9 clinical centers. Patients who meet all eligibility criteria will
 receive the AXIOS stent for up to 60 days indwell and 72 hour follow-up after stent removal.
Inclusion Criteria:

 1. Patient requiring intervention for the management of symptoms associated with acute
 cholecystitis

 2. Patients referred for percutaneous drainage of the gallbladder who are not surgical
 candidates because of advanced age, anesthetic risk, significant co-morbidities and/or
 overall health

 3. Eligible for endoscopic intervention

 4. Acute Cholecystitis (AC) Grade I (mild) or II (moderate) per Tokyo guidelines:

 -  AC Grade I (mild) defined as acute cholecystitis in an otherwise healthy patient
 with mild local inflammatory changes and without organ dysfunction. Criteria for
 grade II or III not met.

 -  AC Grade II (moderate) defined by any one of the following characteristics

 -  Leukocytosis (>18,000 cells per mm3)

 -  Palpable, tender mass in right upper quadrant

 -  Symptom duration >72 hours

 -  Marked local inflammation (gangrenous or emphysematous cholecystitis,
 pericholecystic or hepatic abscess, biliary peritonitis)

 5. Pre-drainage imaging confirms sufficient stone-free space to allow AXIOS™ stent
 deployment and complete flange expansion

 6. 18 years of age or older

 7. Willing and able to comply with the study procedures and patient or legally authorized
 representative (LAR) must provide written informed consent form (ICF) to participate
 in the study

 Exclusion Criteria:

 1. AC Grade III (severe) per Tokyo guidelines defined by organ dysfunction in any one of
 the following systems:

 -  Cardiovascular - Hypotension requiring administration of ≥5μg/kg/min of dopamine
 or any dose of norepinephrine

 -  Neurologic - decreased level of consciousness

 -  Respiratory - PaO2/FiO2 <300

 -  Renal - Oliguria and Creatinine >2.0 mg/dl (>177 μmol/liter)

 -  Hepatic - International normalized ratio >1.5

 -  Hematologic - Platelet count <100,000/mm3

 2. Obvious signs on diagnostic imaging of perforated, extensive gangrenous or ischemic
 gallbladder

 3. Hepatic abscess

 4. Ascites

 5. Patients with abnormal coagulation or who require ongoing complete anticoagulation

 6. Bleeding diathesis

 7. History of surgical treatment of acute cholecystitis (e.g. cholecystectomy)

 8. Patients with a current percutaneous drainage

 9. Patients with a history of percutaneous gallbladder drainage without AC free period
 following percutaneous drainage removal

 10. Distance between gallbladder wall and duodenal or gastric wall > 1cm by US
 (ultrasound) at the time of drainage

 11. Patients with intervening gastric varices or vessels within a one centimeter radius of
 the device insertion location

 12. Patients that have allergies or are sensitive to any of the device materials

 13. Patients with contraindications to use of electrical devices

 14. Pregnancy

 15. Prisoners and other vulnerable populations