Comparison of Covered and Bare Stent in TIPS

NCT ID: NCT02540382

Last Updated: 2015-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 258 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2014-12-31

Brief 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.

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.

Conditions

Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

covered stent

Intervention Type: 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

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.

Group Type: OTHER

bare stent

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Shijitan Hospital, Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Liu Fuquan

Department of Interventional Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianli Xu, MD, PhD

Role: STUDY_CHAIR

Beijing Shijitan Hospital, Capital Medical University

Locations

Beijing Shijitan Hospital

Beijing, Beijing Municipality, China

Countries

China

References

Li HB, Yue ZD, Zhao HW, Wang L, Fan ZH, He FL, Dong XQ, Liu FQ. Pathological Features of Mitochondrial Ultrastructure Predict Susceptibility to Post-TIPS Hepatic Encephalopathy. Can J Gastroenterol Hepatol. 2018 Jul 16;2018:4671590. doi: 10.1155/2018/4671590. eCollection 2018.

Reference Type: DERIVED

PMID: 30079331 (View on PubMed)

Other Identifiers

liufq_sjt

Identifier Type: -

Identifier Source: org_study_id