CompletedNot Applicable

WallFlex Biliary Post Liver Transplant IDE Pilot

United States10 participantsStarted 2009-10

Plain-language summary

The primary objective of this study is to demonstrate effectiveness of the WallFlex Biliary RX Fully Covered Stent for anastomotic biliary strictures in post-orthotopic liver transplant (OLT) patients.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age 18 or older
✓. Post -OLT patients with symptoms of biliary obstruction secondary to anastomotic biliary stricture as assessed by:
✓. Willingness and ability to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion criteria

✕. Roux-en-Y choledochojejunostomy
✕. Suspected nonanastomotic biliary strictures based on imaging(i.e. multiple strictures, strictures that are longer than 8cm in length, strictures located in the intrahepatic ducts and/or in the donor duct proximal to the site of anastomosis)
✕. Living donor transplants
✕. Transplants performed within 30 days (fresh transplants)
✕. Perforation of any duct within the biliary tree
✕. Patients with known sensitivity to any components of the stent or delivery system
✕. Patients with malignancy involving the biliary tree (including hepatocellular carcinoma)
✕. Patients with poor Karnofsky score

What they're measuring

Stricture Resolution at the Time of Stent Removal.

Timeframe: At 3 months (per protocol removal) or at early removal.

Trial details

NCT IDNCT01151280

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-10

Results submitted2013-04-12

View on ClinicalTrials.gov More Anastomotic Biliary Stricture Post Orthotopic Liver Transplant trials