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Cirrhotic Portal HypertensionNCT00593528

PTFE Covered Stents Versus Naked Stents in the TIPS (Transjugular Intra-hepatic Porto-systemic Shunt)

A study testing PTFE Covered Stents: Fluency® (Bard), Advanta V12® (Atrium) and Viatorr® (Gore) and Transjugular intrahepatic portosystemic shunt (TIPS) in people with Cirrhotic Portal Hypertension, run by University Hospital, Tours at 12 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Transjugular intrahepatic portosystemic shunts (TIPS) have been increasingly used for the treatment of complications of portal hypertension in patients with cirrhosis. The initial experiment of the TIPS was reported during the 1990s with stents of various brands, manufacture and sizes, but all "non covered", thus… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cirrhotic Portal Hypertension
What is being tested?
PTFE Covered Stents: Fluency® (Bard), Advanta V12® (Atrium) and Viatorr® (Gore) and Transjugular intrahepatic portosystemic shunt (TIPS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
12 sitesFrance
Study dates
18 Feb 2008to 11 Jul 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Presence of a cirrhosis as documented by previous liverbiopsy or typical clinical signs
  • 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

Who cannot join

  • Non cirrhotic HTP
  • 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
Show all 10Show fewer
  • Pulmonary arterial hypertension (PAP > 40 mmHg)
  • Hepatic polycystosis
  • Intra-hepatic bile ducts dilatation,
  • Spontaneous clinical recurrent hepatic encephalopathy

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

France12 sites

  • Chru Bordeaux

    Bordeaux, 33075

  • Chru Caen

    Caen, 14033

  • Chru Clermont Ferrand

    Clermont-Ferrand, 63058

  • Chru Dijon

    Dijon, 21079

  • AP-HM / La Conception

    Marseille, 13003

  • AP-HM / La Timone

    Marseille, 13385

  • CHRU NANTES / Hôtel-Dieu

    Nantes, 44093

  • CHRU NANTES / Hôpital Guillaume et René Laënnec

    Nantes, 44800

  • Chru Nice

    Nice, 06202

  • Chru Poitiers

    Poitiers, 86021

  • CHRU de TOURS

    Tours, 37044

  • Ap-Hp (Paul Brousse)

    Villejuif, 94804

Other trials in France

About this study

Official title: Randomized Study With Medico-economic Evaluation Comparing the Use of PTFE Covered Stents vs Naked Stent in the TIPS (Transjugular Intra-hepatic Porto-systemic Shunt)

Transjugular intrahepatic portosystemic shunts (TIPS) have been increasingly used for the treatment of complications of portal hypertension in patients with cirrhosis.

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.

Read more

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)
Being tested
Naked Stents: Wallstent® (Boston Scientific), Luminexx® (Bard), Zilver® (Cook), Palmaz Genesis® and Smart Control® (Cordis), PTFE Covered Stents: Fluency® (Bard), Advanta V12® (Atrium) and Viatorr® (Gore), Transjugular intrahepatic portosystemic shunt (TIPS)
Keywords
Cirrhosis, STIC TIPS, Portal Hypertension, Transjugular Intrahepatic Portosystemic Shunt , Stents, PTFE, cirrhotic HTP
Medical subject headings
Fibrosis, Hypertension, Portal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Naked Stents: Wallstent® (Boston Scientific), Luminexx® (Bard), Zilver® (Cook), Palmaz Genesis® and Smart Control® (Cordis)Device

    Vascular Stents

  • PTFE Covered Stents: Fluency® (Bard), Advanta V12® (Atrium) and Viatorr® (Gore)Device

    Vascular Stents

  • Transjugular intrahepatic portosystemic shunt (TIPS)Procedure or surgery

    Transjugular intrahepatic portosystemic shunt (TIPS)

Study groups in NCT00593528
Study groupRoleWhat they receive
AActive comparatorNaked Stents
Receives: Device: Naked Stents: Wallstent® (Boston Scientific), Luminexx® (Bard), Zilver® (Cook), Palmaz Genesis® and Smart Control® (Cordis); Procedure: Transjugular intrahepatic portosystemic shunt (TIPS)
BExperimentalPTFE Covered Stents
Receives: Device: PTFE Covered Stents: Fluency® (Bard), Advanta V12® (Atrium) and Viatorr® (Gore); Procedure: Transjugular intrahepatic portosystemic shunt (TIPS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. TIPS permeability rate

    Measured: one year

  2. Cost of the TIPS and patient care according to the type of stent used brought back to an indicator of effectiveness

    Measured: one year

Secondary outcomes (4)

  1. Tolerance criteria : frequency of early complications like early thrombosis - probability of hepatic encephalopathy occurrence and gravity

    Measured: one year

  2. Quality of life

    Measured: one year

  3. Effectiveness criteria : survival rate - recurrence rate of the symptoms having justified the TIPS - various types of dysfunction

    Measured: one year

  4. Doppler : performance evaluation of Doppler for the diagnosis of dysfunction

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2008 (estimated)
  2. Study start18 Feb 2008
  3. Primary completion11 Jul 2011
  4. Study completion11 Jul 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00593528
Sponsor's protocol ID
STIC07-JMP/TIPS-PTFE
Other IDs
2007-A00857-46
Status last verified
Dec 2025
First submitted
17 Dec 2007
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 1836597

  • 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.

    PubMed 14762784

  • 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.

    PubMed 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.

    PubMed 14512892

  • 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.

    PubMed 15525740

  • 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.

    PubMed 15950109

  • 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.

    PubMed 16037523

  • 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.

    PubMed 16950701

  • 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.

    PubMed 16908675

  • 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.

    PubMed 17033430

  • 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, 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.

    PubMed 24480619

Questions about this trial

What is this clinical trial studying?

A study testing PTFE Covered Stents: Fluency® (Bard), Advanta V12® (Atrium) and Viatorr® (Gore) and Transjugular intrahepatic portosystemic shunt (TIPS) in people with Cirrhotic Portal Hypertension, run by University Hospital, Tours at 12 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TIPS permeability rate (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00593528, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.

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