Lower limb or/and pelvic venous reflux caused by Iliac vein stenosis or occlusion
Conditions
Interventions
Experimental group:Vein Stent System
Control group:Zilver Vena
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years; 2. iliac vein stenosis >=50% or occlusion (DSAorCTV); 3. CEAP clinical grade C >=3; 4. patients voluntarily sign informed consent and complete follow-up.
Exclusion criteria
Exclusion criteria: 1. Stenting parts always underwent interventional surgery or for previous surgery patients with stent placement; 2. Iliac vein stricture was caused by pelvic tumor compression, caused by tumor after radiotherapy, thrombosis syndrome (PTS), half a year internal cause diagnosis of acute lower extremity deep vein thrombosis (DVT) catheter thrombolysis or should left iliac vein stricture postoperatively; 3. subjects are allergic to contrast agents and anesthetics; 4. Serious patients had coagulant function abnormality; 5. Patients with severe liver and kidney dysfunction; 6. By reason of malignant tumor, life expectancy of patients less than 12 months; 7. Iliac vein of iliac vein stent system shall not apply to the specifications; 8. To the product material (nickel titanium and tantalum) patients with a history of allergies; 9. 12 months of men and women have fertility planning; 10. The researchers determine patient adherence is poor, can't do research according to the requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patency rate of vein 12 months after operation; | — |
Countries
China
Contacts
Public ContactXiaoqiang Li
Intervention Department, Nanjing Drum Tower Hospital
Outcome results
None listed