PTFE Covered Stents Versus Naked Stents in the TIPS (Transjugular Intra-hepatic Porto-systemic Shunt)
NCT ID: NCT00593528
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
138 participants
INTERVENTIONAL
2008-02-18
2011-07-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The initial experiment of the TIPS was reported during the 1990s with stents of various brands, manufacture and sizes, but all "non covered", thus owing the pseudointimal hyperplasia growing inside the stent, which progressively decreases the diameter of the shunt and thus its efficacy. Since the beginning of the 2000s, appeared stents known as "covered" by polytetrafluoroethylene (PTFE) designed to reduce the obstruction rate and thus the frequency shunt revisions. However, these stents are, on average, 2.5 times more expensive than the non covered stents and the cost-effectiveness ratio of the TIPS according to the type of stents used has not been assessed.
The aim of this multicentric and randomized study is to assess the cost-effectiveness ratio of these 2 principles of TIPS, the one using stents covered by PTFE, relatively expensive but seldom becoming obstructed, and the other using non covered stents, less expensive than PTFE but requiring regular gestures of redilatation.
Population concerned: Patients with a cirrhotic portal hypertension responsible for:
* recurrent variceal bleeding
* refractory ascite (or hydrothorax)
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A
Naked Stents
Naked Stents: Wallstent® (Boston Scientific), Luminexx® (Bard), Zilver® (Cook), Palmaz Genesis® and Smart Control® (Cordis)
Vascular Stents
Transjugular intrahepatic portosystemic shunt (TIPS)
Transjugular intrahepatic portosystemic shunt (TIPS)
B
PTFE Covered Stents
PTFE Covered Stents: Fluency® (Bard), Advanta V12® (Atrium) and Viatorr® (Gore)
Vascular Stents
Transjugular intrahepatic portosystemic shunt (TIPS)
Transjugular intrahepatic portosystemic shunt (TIPS)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Naked Stents: Wallstent® (Boston Scientific), Luminexx® (Bard), Zilver® (Cook), Palmaz Genesis® and Smart Control® (Cordis)
Vascular Stents
PTFE Covered Stents: Fluency® (Bard), Advanta V12® (Atrium) and Viatorr® (Gore)
Vascular Stents
Transjugular intrahepatic portosystemic shunt (TIPS)
Transjugular intrahepatic portosystemic shunt (TIPS)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Indication validated of the TIPS (Bavéno IV), except not-controlled acute hemorrhagic :
* Recurrent variceal bleeding after failure of the usual pharmacological and endoscopic methods
* Refractory or recurrent ascites or difficult to treat
* Refractory Hydrothorax
Exclusion Criteria
* CHILD C ≥12
* Complete portal vein thrombosis
* Usual contra-indication for TIPS :
* Known or suspected Hepatocarcinoma by increase of the alpha-foetoprotein \>100 UI/mL associated with the presence of at least one hepatic nodule
* Cardiac insufficiency defined by a ventricular fraction of ejection \< 40% with the echocardiography preliminary to the procedure
* Pulmonary arterial hypertension (PAP \> 40 mmHg)
* Hepatic polycystosis
* Intra-hepatic bile ducts dilatation,
* Spontaneous clinical recurrent hepatic encephalopathy
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Tours
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jean-Marc PERARNAU, Doctor
Role: PRINCIPAL_INVESTIGATOR
CHRU TOURS
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chru Bordeaux
Bordeaux, , France
Chru Caen
Caen, , France
Chru Clermont Ferrand
Clermont-Ferrand, , France
Chru Dijon
Dijon, , France
AP-HM / La Conception
Marseille, , France
AP-HM / La Timone
Marseille, , France
CHRU NANTES / Hôtel-Dieu
Nantes, , France
CHRU NANTES / Hôpital Guillaume et René Laënnec
Nantes, , France
Chru Nice
Nice, , France
Chru Poitiers
Poitiers, , France
CHRU de TOURS
Tours, , France
Ap-Hp (Paul Brousse)
Villejuif, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Tripathi D, Redhead D. Transjugular intrahepatic portosystemic stent-shunt: technical factors and new developments. Eur J Gastroenterol Hepatol. 2006 Nov;18(11):1127-33. doi: 10.1097/01.meg.0000236871.78280.a7.
Riggio O, Angeloni S, Nicolao F, Ridola L, Salvatori FM et al. Hepatic Encephalopathy is more frequent and severe after Transjugular intrahepatic portosystemeic Shunt (TIPS) with PTFE-coveted stent-grafts. Hepatology 2006;44, suppl 1, 232
Perarnau JM, Noeldge G, Rossle M. [Intrahepatic portacaval anastomosis by the transjugular approach. Use of the Palmaz endoprosthesis]. Presse Med. 1991 Nov 9;20(36):1770-2. French.
Bureau C, Garcia-Pagan JC, Otal P, Pomier-Layrargues G, Chabbert V, Cortez C, Perreault P, Peron JM, Abraldes JG, Bouchard L, Bilbao JI, Bosch J, Rousseau H, Vinel JP. Improved clinical outcome using polytetrafluoroethylene-coated stents for TIPS: results of a randomized study. Gastroenterology. 2004 Feb;126(2):469-75. doi: 10.1053/j.gastro.2003.11.016.
Nishimine K, Saxon RR, Kichikawa K, Mendel-Hartvig J, Timmermans HA, Shim HJ, Uchida BT, Barton RE, Keller FS, Rosch J. Improved transjugular intrahepatic portosystemic shunt patency with PTFE-covered stent-grafts: experimental results in swine. Radiology. 1995 Aug;196(2):341-7. doi: 10.1148/radiology.196.2.7617843.
Angermayr B, Cejna M, Koenig F, Karnel F, Hackl F, Gangl A, Peck-Radosavljevic M; Vienna TIPS Study Group. Survival in patients undergoing transjugular intrahepatic portosystemic shunt: ePTFE-covered stentgrafts versus bare stents. Hepatology. 2003 Oct;38(4):1043-50. doi: 10.1053/jhep.2003.50423.
Charon JP, Alaeddin FH, Pimpalwar SA, Fay DM, Olliff SP, Jackson RW, Edwards RD, Robertson IR, Rose JD, Moss JG. Results of a retrospective multicenter trial of the Viatorr expanded polytetrafluoroethylene-covered stent-graft for transjugular intrahepatic portosystemic shunt creation. J Vasc Interv Radiol. 2004 Nov;15(11):1219-30. doi: 10.1097/01.RVI.0000137434.19522.E5.
Barrio J, Ripoll C, Banares R, Echenagusia A, Catalina MV, Camunez F, Simo G, Santos L. Comparison of transjugular intrahepatic portosystemic shunt dysfunction in PTFE-covered stent-grafts versus bare stents. Eur J Radiol. 2005 Jul;55(1):120-4. doi: 10.1016/j.ejrad.2004.10.007.
Vignali C, Bargellini I, Grosso M, Passalacqua G, Maglione F, Pedrazzini F, Filauri P, Niola R, Cioni R, Petruzzi P. TIPS with expanded polytetrafluoroethylene-covered stent: results of an Italian multicenter study. AJR Am J Roentgenol. 2005 Aug;185(2):472-80. doi: 10.2214/ajr.185.2.01850472.
Rossle M, Siegerstetter V, Euringer W, Olschewski M, Kromeier J, Kurz K, Langer M. The use of a polytetrafluoroethylene-covered stent graft for transjugular intrahepatic portosystemic shunt (TIPS): Long-term follow-up of 100 patients. Acta Radiol. 2006 Sep;47(7):660-6. doi: 10.1080/02841850600806324.
Gandini R, Konda D, Simonetti G. Transjugular intrahepatic portosystemic shunt patency and clinical outcome in patients with Budd-Chiari syndrome: covered versus uncovered stents. Radiology. 2006 Oct;241(1):298-305. doi: 10.1148/radiol.2411050347. Epub 2006 Aug 14.
Perarnau JM, Le Gouge A, Nicolas C, d'Alteroche L, Borentain P, Saliba F, Minello A, Anty R, Chagneau-Derrode C, Bernard PH, Abergel A, Ollivier-Hourmand I, Gournay J, Ayoub J, Gaborit C, Rusch E, Giraudeau B; STIC-TIPS group. Covered vs. uncovered stents for transjugular intrahepatic portosystemic shunt: a randomized controlled trial. J Hepatol. 2014 May;60(5):962-8. doi: 10.1016/j.jhep.2014.01.015. Epub 2014 Jan 27.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STIC07-JMP/TIPS-PTFE
Identifier Type: -
Identifier Source: org_study_id
2007-A00857-46
Identifier Type: OTHER
Identifier Source: secondary_id