Comparison of Covered and Bare Stent in TIPS

Cirrhosis Clinical Trial

Official title:

Comparison of Covered and Bare Stent in TIPS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02540382
• Other study ID #: liufq_sjt
• Status: Completed
• Phase: N/A
• First received: August 27, 2015
• Last updated: September 1, 2015
• Start date: January 2006
• Est. completion date: December 2014

Study information

• Verified date: September 2015
• Source: Beijing Shijitan Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Health Bureau
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cirrhosis

Intervention

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
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.

Locations

Country	Name	City	State
China	Beijing Shijitan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Shijitan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	restenosis/occlusion rate	The cumulative restenosis rate in 1, 2, 3, 4, or 5-year	up to 5 years	No
Secondary	recurrence rate of gastrointestinal bleeding		up to 5 years	No
Secondary	recurrence rate of refractory hydrothorax/ascites	the recurrence rate of refractory hydrothorax/ascites (including non-responders, recurrent, and newly developed cases) during the follow up	up to 5 years	No
Secondary	survival rate	The 1, 2, 3, 4 and 5-year survival rate	up to 5 years	No
Secondary	rate of secondary interventional therapy	rate of secondary interventional therapy	up to 5 years	No
Secondary	incidence rate of hepatic encephalopathy	The incidence rate of hepatic encephalopathy	up to 5 years	No