iliac vein compression syndrome
Conditions
Interventions
test group:the new iliac vein stent
control group :the zilver vena stent
Sponsors
First Affiliated Hospital of USTC(Anhui Provincial Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18 = 75; Gender is not limited; 2. Iliac vein stenosis: = 50% (DSA or CTV); 3. Clinical classification of CEAP: = C3; 4. Subjects or their legal guardians can understand the purpose of the trial, are willing to cooperate with interventional surgery and follow-up, voluntarily participate in the trial and sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients with previous interventional surgery in target iliac vein; 2.Iliac vein stenosis caused by pelvic tumor compression, previous radiotherapy, post-thrombotic syndrome (medical history and doppler ultrasound examination)iliac vein stenosis after catheterization thrombolysis or thrombectomy due to DVT within half a year; 3.Contraindicated to contrast agent or anticoagulant drugs; 4.Severe abnormal blood coagulation; 5.Severe hepatic and/or renal insufficiency; 6.Life expectancy less than 12 months; 7.Iliac vein size not applicable to vein stent; 8.History of allergy to materials (nickel titanium and tantalum; 9.Men or women who plan to have children during pregnancy, lactation or within 12 months; 10.Patients who has participated in, is participating in, or plans to participate in any other device or drug clinical trial within 3 months prior to screening; 11.Patients considered unsuitable for this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patency rate of iliac vein 12 months after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate and defect rate of the stent;Minimum lumen diameter and diameter stenosis of iliac vein 12 months after surgery;Surgical success rate;Changes in venous clinical severity (VCSS) scores at 3 and 12 months postoperatively;CEAP grading was performed 3 and 12 months after surgery; | — |
Countries
China
Contacts
Public ContactHeJie Hu
First Affiliated Hospital of USTC(Anhui Provincial Hospital)
Outcome results
None listed