Iliofemoral vein obstructive disease
Conditions
Interventions
treatment group:Venous stent system
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Participants aged 18 to 75 years who are not pregnant or nursing; 2. Symptomatic stenosis or occlusion of unilateral common iliac vein, external iliac vein, and common femoral vein (angiography indicates target vessel stenosis >=75%); 3. CEAP rating >=3 or VCSS rating >=2; 4. Subjects who can understand the purpose of the trial, voluntarily participate and sign informed consent, and are willing to follow up.
Exclusion criteria
Exclusion criteria: 1. iliac vein occlusion involving inferior vena cava; 2. There is no incoming channel; 3. The target lesion has been previously implanted with a stent; 4. Fatal pulmonary embolism occurred within 6 months prior to signing the informed consent form; 5. Subjects with a history of active bleeding, coagulation disorder (INR >=2.0), or refusal of transfusion; 6. Subjects with liver, kidney and other important organ failure; 7. Subjects allergic to contrast media, Nitinol, tantalum and other stent materials; 8. Participants who are currently or have been enrolled in another clinical trial within the last 30 days; 9. Subjects with a life expectancy of less than 12 months (e.g. advanced malignancy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major adverse events at 30 days;patency rate of target lesions at 12 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Instrument success rate;Technical success rate;success rate of operation;Patency rate of target lumen 6 months and 2 to 5 years after operation;Changes of CEAP score 6 and 12 months after operation;Changes of VCSS score 6 and 12 months after surgery;Changes of VIVIQ-14 scores 6 and 12 months after surgery;Incidence of target vessel revascularization 6 and 12 months after operation;Incidence of adverse events at 6, 12 months and 2-5 years after surgery; | — |
Countries
China
Contacts
Public ContactZheng Yuehong
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed