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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
258
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
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.
Beijing Shijitan Hospital
Beijing, Beijing Municipality, China
restenosis/occlusion rate
The cumulative restenosis rate in 1, 2, 3, 4, or 5-year
Time frame: up to 5 years
recurrence rate of gastrointestinal bleeding
Time frame: up to 5 years
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
Time frame: up to 5 years
survival rate
The 1, 2, 3, 4 and 5-year survival rate
Time frame: up to 5 years
rate of secondary interventional therapy
rate of secondary interventional therapy
Time frame: up to 5 years
incidence rate of hepatic encephalopathy
The incidence rate of hepatic encephalopathy
Time frame: up to 5 years
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