Skip to main content
OpenTrials
Completed

NCT Number: NCT02540382

Comparison of Covered and Bare Stent in TIPS

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cirrhosis Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Fibrosis Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Shijitan Hospital

Beijing, Beijing Municipality, 100038, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • combined with hepatic encephalopathy before the treatment;
  • combined with portal vein thrombosis;
  • combined with malignant liver tumor or malignancies at the other sites; or
  • combined with hemorrhage of gastrointestinal ulcer.

Treatment and study plan

covered stent

Device

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

Device

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.

Primary outcomes

  1. restenosis/occlusion rate

    Time frame: up to 5 years

    The cumulative restenosis rate in 1, 2, 3, 4, or 5-year

Secondary outcomes

  1. recurrence rate of gastrointestinal bleeding

    Time frame: up to 5 years

  2. recurrence rate of refractory hydrothorax/ascites

    Time frame: up to 5 years

    the recurrence rate of refractory hydrothorax/ascites (including non-responders, recurrent, and newly developed cases) during the follow up

  3. survival rate

    Time frame: up to 5 years

    The 1, 2, 3, 4 and 5-year survival rate

  4. rate of secondary interventional therapy

    Time frame: up to 5 years

    rate of secondary interventional therapy

  5. incidence rate of hepatic encephalopathy

    Time frame: up to 5 years

    The incidence rate of hepatic encephalopathy

Sponsors and collaborators

Lead sponsor

Beijing Shijitan Hospital, Capital Medical University

Other

Registry information

Important dates

Study start
2006
Primary completion
2014
Study completion
2014
First posted
Sep 3, 2015
Registry last updated
Sep 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.