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Comparison of Covered and Bare Stent in TIPS

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Liu Fuquan, Beijing Shijitan Hospital
ClinicalTrials.gov Identifier:
NCT02540382
First received: August 27, 2015
Last updated: September 1, 2015
Last verified: September 2015
  Purpose

Investigators aim to compare the efficacy of 8 mm Fluency covered stent and bare stent in transjugular intrahepatic portosystemic shunt (TIPS) for the treatment of cirrhotic portal hypertension.


Condition Intervention
Cirrhosis
Device: covered stent
Device: bare stent

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Covered and Bare Stent in TIPS

Resource links provided by NLM:


Further study details as provided by Beijing Shijitan Hospital:

Primary Outcome Measures:
  • restenosis/occlusion rate [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    The cumulative restenosis rate in 1, 2, 3, 4, or 5-year


Secondary Outcome Measures:
  • recurrence rate of gastrointestinal bleeding [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • recurrence rate of refractory hydrothorax/ascites [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    the recurrence rate of refractory hydrothorax/ascites (including non-responders, recurrent, and newly developed cases) during the follow up

  • survival rate [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    The 1, 2, 3, 4 and 5-year survival rate

  • rate of secondary interventional therapy [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    rate of secondary interventional therapy

  • incidence rate of hepatic encephalopathy [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    The incidence rate of hepatic encephalopathy


Enrollment: 258
Study Start Date: January 2006
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: covered stent

Procedure/Surgery: Jugular vein puncture and catheterization. Device: RUPS-100 (COOK Company) sheath, 8 mm balloon, Pigtail catheter, 8 mm covered stents (Bard, Fluency).

Drug (including placebo): No Biological/Vaccine: No Radiation: No Behavioral (e.g., Psychotherapy, Lifestyle Counseling): No Genetic (including gene transfer, stem cell and recombinant DNA): No Dietary Supplement (e.g., vitamins, minerals): No.

Device: covered stent
A broad range of implant diameters and lengths for the treatment of in-stent restenotic peripheral and central lesions* in patients with AV grafts and AV fistulae Small incremental stent graft lengths to help maintain venous real estate and cannulation area Minimal shortening and radiopaque markers aid in excellent placement accuracy
bare stent

Surgery: Jugular vein puncture and catheterization. Device: RUPS-100 (COOK Company) sheath, 8 mm balloon, Pigtail catheter, 8 mm bare stents (EV3, protégé; Cordis, Smart).

Drug (including placebo): No Biological/Vaccine: No Radiation: No Behavioral (e.g., Psychotherapy, Lifestyle Counseling): No Genetic (including gene transfer, stem cell and recombinant DNA): No Dietary Supplement (e.g., vitamins, minerals): No.

Device: bare stent

A one piece laser cut, self-expanding nitinol stent combining a micromesh design with a multi segmental construction.

The 36 strut, 6 bridge construction of the Stent provides an unmatched balance of radial force, scaffolding, and longitudinal stability.

The design offers crush recoverable flexibility in the most challenging vasculature, with optimal wall apposition, conformability and minimal foreshortening.

It offers a broad portfolio of sizes for the treatment of routine and challenging Iliofemoral lesions.


Detailed Description:

From January 2006 to December 2010, the covered (experimental group) or bare stent (control group) was used in 131 and 127 patients, respectively. The recurrence rates of gastrointestinal bleeding and refractory hydrothorax/ascites, the cumulative restenosis rates in 1, 2, 3, 4, and 5-years, the incidence rate of hepatic encephalopathy, the rate of secondary interventional therapy, the 1, 2, 3, 4 and 5-year survival rates were compared between the experimental group and the control group.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. portal hypertension patients with defined indications for TIPS treatment;
  2. scheduled for elective TIPS; and
  3. aged between 18-70 years.

Exclusion Criteria:

  1. combined with hepatic encephalopathy before the treatment;
  2. combined with portal vein thrombosis;
  3. combined with malignant liver tumor or malignancies at the other sites; or
  4. combined with hemorrhage of gastrointestinal ulcer.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02540382

Locations
China, Beijing
Beijing Shijitan Hospital
Beijing, Beijing, China, 100038
Sponsors and Collaborators
Beijing Shijitan Hospital
Investigators
Study Chair: Jianli Xu, MD, PhD Beijing Shijitan Hospital of Capital Medical University
  More Information

No publications provided

Responsible Party: Liu Fuquan, Department of Interventional Therapy, Beijing Shijitan Hospital
ClinicalTrials.gov Identifier: NCT02540382     History of Changes
Other Study ID Numbers: liufq_sjt
Study First Received: August 27, 2015
Last Updated: September 1, 2015
Health Authority: China: Beijing Municipal Health Bureau

Keywords provided by Beijing Shijitan Hospital:
TIPS
Hepatocellular Carcinoma
Portasystemic Shunt

ClinicalTrials.gov processed this record on September 02, 2015