A Prospective, Multi-center, Single-arm, Post Market Observational Study to Evaluate the Safety and Clinical Performance of the Archimedes Biodegradable Biliary and Pancreatic Stent
A Prospective, Multi-center, Single-arm, Post Market Observational Study to Evaluate the Safety and Clinical Performance of the Archimedes Biodegradable Biliary and Pancreatic Stent
Significant experience with biodegradable materials has been reported in the orthopedic
 literature; in particular; biodegradable stents have been used in the endovascular and
 urologic epithelium. Stents are typically made from polymeric materials including Polylactic
 Acid (PLA), Polyglycolide (PGA), Polydioxanone (PDO), Polyethyleneglycol (PEG),
 Polycaprolactone (PCL), etc., which have been cleared or approved by the FDA and CE-marked as
 drug carriers, sutures, and bone fixatives. The material is degraded by hydrolysis in, e.g.,
 lactic acid, which is removed from the body by normal metabolic pathways. In the field of
 gastroenterology, these stents were first introduced in patients with an esophageal stenosis
 with encouraging results, although esophageal hyperplasia was a frequently encountered
 complication.

 For biliary applications, biodegradable stents have been evaluated in several in-vitro and
 animal studies that demonstrated that the stents were safe and well tolerated. These stents
 provided an adequate radial force and resulted in complete stricture resolution within
 several months. The stents did not show any signs of biliary hyperplasia or integration in
 the epithelium. Moreover, they seem to have a self-clearing effect on attached biofilm as the
 outer layer sloughs during the degradation process similarly to the exfoliation of human
 skin. Also, the stent could be removed from the bile duct, thus offering the possibility of
 extraction if necessary at various times after implantation.

 In 2010, Petryl was the first to use a biodegradable stent in the human bile duct. A stent
 was successfully placed using percutaneous transhepatic cholangiograpy in two patients with a
 postsurgical intrahepatic biliary stricture. Transient cholangitis was the only complication
 encountered and during the two years of follow-up, the bile duct remained patent.

 Later, Mauri et al. presented in 2013 and 2016 results of a 107 patient study on a
 polydioxanone biodegradable biliary stent. The results have been published in the Journal of
 the European Society of Radiology. The authors concluded that percutaneous placement of a
 biodegradable biliary stent is a feasible and safe strategy to treat benign biliary
 strictures refractory to standard bilioplasty, with promising results in the mid-term period.

 Prior to this study, the ARCHIMEDES device was assessed in the ARCHIMEDES Investigational
 study which has completed enrolment with 53 patients included, and the results are not yet
 published. In this study approximately half the stents were deployed in the bile duct (53%)
 and half in the pancreatic duct. All 53 patients have either completed, exited, or no longer
 have the study device. No patient remains in the study with a stent in place during the time
 of the last patient follow-ups. The study concluded without any device-related SAE. Bilirubin
 was reduced by 25.6%, which exceeded the >20% clinical success criterion, quality of life
 score improved from 3.7 to 7.9, procedural success was rated 1.4 (good to excellent), and
 technical success was achieved in all 53 patients.

 Data from the ARCHIMEDES Investigational study was used for CE Mark approval, which was
 obtained in June 2018.
Inclusion Criteria:

 -  Patient eligible for implantation of a pancreatic or billiary stent prior to
 participate in the study and according to current guidelines

 -  Patient has provided a signed and dated informed consent (according to the laws and
 regualtions of the country in which the observational study is conducted)

 Exclusion Criteria:

 -  Age < 18 y

 -  Inability to understand the purpose of the study or refusal to cooperate

 -  Not available for routine follow-up visits

 -  Pregnancy

 -  Currently participating in a confounding trial before reaching first endpoint.