Venous return disorders
Conditions
Interventions
Experimental group:Release of test instruments after thrombus clearance
Sponsors
The Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects = 18 years of age and = 75 years of age who are not pregnant or lactating 2. Stenosis or occlusion of the total iliac vein, extrailiac vein, and common femoral vein (contrast suggests lumen stenosis of the target lesion=50%) 3. CEAP clinical grade = 3 or VCSS score = 2 points 4. The subject or his/her guardian understands the purpose of the trial, is willing to cooperate with interventional surgery and follow-up, voluntarily participates in the trial and signs a written informed consent
Exclusion criteria
Exclusion criteria: 1. Occlusive iliac vein involves the inferior vena cava 2. Patients with target lesions who have previously been implanted with stents or undergoing surgical open surgery 3. Patients who need to be stented at the same time as bilateral total iliac and extrailiac and common femoral veins 4. High-risk pulmonary embolism occurs within 6 months prior to signing the informed consent form 5. Patients with iliofemoral vein obstruction caused by tumor compression 6. Platelet count = 50×109/L in patients with severe coagulation dysfunction or uncontrollable active bleeding disorders 7. Patients with anticoagulation contraindications 8. Patients with liver and kidney failure 9. Patients with a life expectancy of less than 12 months due to malignant tumors and other reasons 10. Patients with a history of allergy to contrast agents and product materials (Nitinol alloys). 11. Men or women who have a birth plan within the next 1 year 12. Patients currently or in the last 30 days who have participated in other clinical trials 13. Patients who are deemed unsuitable for this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Luminal patency of target lesions 12 months postoperatively;Incidence of MAE (major adverse events) at 30 days postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| 6 months after surgery, 2-5 years after the target lesion lumen patency rate;Device success rate;Technical success rate;Surgical success rate;Changes in clinical grade of CCAP 6 to 12 months after surgery;VCSS score changed 6 to 12 months after surgery;The CIVIQ-14 score changed at 6, 12 months, and 2-5 years after surgery;The incidence of revascularization of target lesions at 30 days, 6, 12 months, and 2-5 years after surgery;The incidence of target vascular revascularization at 30 days, 6, 12 months, and 2-5 years after surgery;Adverse event rates at 30 days, 6, 12 months, and 2-5 years after surgery; | — |
Countries
China
Contacts
Public ContactLu xinwu
The Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed