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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT00593528
First received: December 17, 2007
Last updated: September 11, 2012
Last verified: September 2012
History of Changes
  Purpose

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.

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)

Condition Intervention
Cirrhotic Portal Hypertension
 Device: Naked Stents: Wallstent® (Boston Scientific), Luminexx® (Bard), Zilver® (Cook), Palmaz Genesis® and Smart Control® (Cordis)
Device: PTFE Covered Stents: Fluency® (Bard), Advanta V12® (Atrium) and Viatorr® (Gore)
Procedure: Transjugular intrahepatic portosystemic shunt (TIPS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:
  • TIPS permeability rate [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Cost of the TIPS and patient care according to the type of stent used brought back to an indicator of effectiveness [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tolerance criteria : frequency of early complications like early thrombosis - probability of hepatic encephalopathy occurrence and gravity [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Effectiveness criteria : survival rate - recurrence rate of the symptoms having justified the TIPS - various types of dysfunction [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Doppler : performance evaluation of Doppler for the diagnosis of dysfunction [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 138
Study Start Date: February 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Naked Stents
 Device: Naked Stents: Wallstent® (Boston Scientific), Luminexx® (Bard), Zilver® (Cook), Palmaz Genesis® and Smart Control® (Cordis)
Vascular Stents
Procedure: Transjugular intrahepatic portosystemic shunt (TIPS)
Transjugular intrahepatic portosystemic shunt (TIPS)
Experimental: B
PTFE Covered Stents
 Device: PTFE Covered Stents: Fluency® (Bard), Advanta V12® (Atrium) and Viatorr® (Gore)
Vascular Stents
Procedure: Transjugular intrahepatic portosystemic shunt (TIPS)
Transjugular intrahepatic portosystemic shunt (TIPS)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
    • Pulmonary arterial hypertension (PAP > 40 mmHg)
    • Hepatic polycystosis
    • Intra-hepatic bile ducts dilatation,
    • Spontaneous clinical recurrent hepatic encephalopathy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00593528

Locations
France
Chru Bordeaux
Bordeaux, France, 33075
Chru Caen
Caen, France, 14033
Chru Clermont Ferrand
Clermont Ferrand, France, 63058
Chru Dijon
Dijon, France, 21079
AP-HM / La Conception
Marseille, France, 13003
AP-HM / La Timone
Marseille, France, 13385
CHRU NANTES / Hôtel-Dieu
Nantes, France, 44093
CHRU NANTES / Hôpital Guillaume et René Laënnec
Nantes (st Herblain), France, 44800
Chru Nice
Nice, France, 06202
Chru Poitiers
Poitiers, France, 86021
Chru Tours
Tours, France, 37000
Ap-Hp (Paul Brousse)
Villejuif, France, 94804
Sponsors and Collaborators
University Hospital, Tours
Investigators
Principal Investigator: Jean-Marc PERARNAU, Doctor CHRU TOURS
  More Information

Publications:
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

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT00593528     History of Changes
Other Study ID Numbers: STIC07-JMP/TIPS-PTFE, 2007-A00857-46
Study First Received: December 17, 2007
Last Updated: September 11, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Tours:
Cirrhosis, STIC TIPS, Portal Hypertension, Transjugular Intrahepatic Portosystemic Shunt , Stents, PTFE
cirrhotic HTP

Additional relevant MeSH terms:
Hypertension
Hypertension, Portal
Vascular Diseases
 Cardiovascular Diseases
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013