Obstructive iliofemoral vein disease
Conditions
Interventions
Experimental group:Venous stent
Sponsors
Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients =18 years old and =75 years old who are not pregnant or lactating; 2. Stenosis or occlusion of common iliac vein, external iliac vein and common femoral vein (angiography indicated target vessel stenosis =50%); 3. CEAP rating =3 or VCSS score =2; 4. Patients 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. Iliac vein occlusion involves inferior vena cava; 2. Patients with target lesions who had previously implanted stents or undergone open surgery; 3. Patients who need to implant stents simultaneously in bilateral common iliac, external iliac and common femoral veins 4. High risk pulmonary embolism occurred within 6 months before signing the informed consent; 5. Patients with iliofemoral vein obstruction caused by tumor compression; 6. Patients with severe coagulation dysfunction or uncontrolled active hemorrhagic disease; 7. Patients with anticoagulation contraindications. 8. Patients with liver, kidney and other important organ failure; 9. Patients with a life expectancy of less than 12 months due to malignant tumors and other causes; 10. Patients with allergic history to contrast media and product material (Nitinol); 11. Men or women who plan to have children in the next five years; 12. Patients participating in other clinical trials currently or within the last 30 days; 13. Patients deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of MAE (major adverse events) at 30 days after surgery;Patency rate of target lumen 12 months after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Instrument success rate;Technical success rate;Operation success rate;Patency rate of target lumen 6 months and 2 to 5 years after operation;Changes of VCSS score 6 and 12 months after surgery;Changes of CEAP rating 6 and 12 months after surgery;Changes of CIVIQ-14 scores 6 and 12 months after surgery;Incidence of target lesion revascularization 30 days, 6 months, 12 months, and 2-5 years after surgery;Incidence of target vessel revascularization at 30 days, 6 months, 12 months, and 2-5 years after surgery;Incidence of adverse events 30 days, 6 months, 12 months, and 2-5 years after surgery; | — |
Countries
China
Contacts
Public ContactWang Wei
Xiangya Hospital Central South University
Outcome results
None listed