AXIOS Stent & Delivery System Study

• Safety - Freedom from major complications [ Time Frame: Through the duration of the 1-week post-stent removal study period ] [ Designated as safety issue: Yes ]
  • Absence of access site-related bleeding requiring transfusion
  • Absence of access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization
  • Absence of tissue injury, defined as ulceration to the submucosa at the site of stent implant.
  • No surgery for access-site related perforation required
  • No stent migration/dislodgement into the pseudocyst or enteral lumen.
  • No serious adverse event classified as implant-associated or implant/surgical procedure-associated;
  
  

• Effectiveness [ Time Frame: @ 30 days and/or 60 days post-procedure follow-up ] [ Designated as safety issue: No ]
  • Stent lumen patency at 30 days and/or 60 days.
  • Stent removability at 30 days and/or 60 days.
  • Technical Success: Successful placement of the AXIOS stent using the AXIOS delivery system and successful removal of the AXIOS stent using a standard endoscopic snare.
  • Clinical Success: At least 50% decrease in pseudocyst size, based on radiographic analysis at 30 days and/or 60 days.
  
  

OBJECTIVE:

To demonstrate the safety and effectiveness of the Xlumena AXIOS Stent and Delivery System for endoscopic drainage of pancreatic pseudocysts in patients with symptomatic pancreatic pseudocysts that are greater than or equal to 6 cm (≥6cm) in diameter, have ≥ 70% fluid contents and are adherent to the bowel wall.

STUDY DESIGN:

Prospective, multi-center, non-blinded, single-arm (nonrandomized) study

KEY ENDPOINTS:

Safety: The safety endpoint is freedom from major complications through the duration of the 1-week post-stent removal study period, defined as:

1. Access site-related bleeding requiring transfusion;
2. Access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization;
3. Surgery for access-site related perforation;
4. Stent migration/dislodgement into the pseudocyst or enteral lumen;
5. Tissue injury, defined as ulceration to the submucosa at site of stent implant as observed to persist through 1-week post-stent removal.
6. Serious adverse event classified as implant-associated or implant/endoscopic procedure-associated;

Effectiveness:

1. Stent lumen patency at 30 days and/or 60 days
2. Stent removability at 30 days and/ or 60 days.
3. Technical success, defined as: placement of the AXIOS stent using the AXIOS delivery system and removal of the AXIOS stent using a standard endoscopic snare.
4. Clinical success, defined as: at least a 50% decrease in pseudocyst size, based on radiographic analysis, at 30 days and/or 60 days.

PATIENT POPULATION:

Patients between 18 and 75 years of age, suitable for transluminal drainage of symptomatic pancreatic pseudocysts that are greater than or equal to 6 cm in diameter and adherent to the bowel wall are candidates for study treatment.

FOLLOW-UP SCHEDULE:

Clinical follow-up evaluations of study endpoints will be conducted at 30 days and/or 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal.

PLANNED NUMBER OF PATIENTS, SITES & REGIONS:

The target enrollment for the study is 24 subjects. Study will be conducted at up to 10 investigational sites in the United States, Japan and/or the European Community. A majority of the patients will be enrolled in the United States.