Iliac Vein Occlusion, Iliac Vein Stenosis
Conditions
Keywords
Peripheral venous stent system, Iliac vein patency rate
Brief summary
Clinical study on safety and efficacy of Zylox peripheral venous stent system in the treatment of iliac vein stenosis or occlusion.
Detailed description
The purpose of this study was to evaluate the safety and efficacy of Zylox peripheral venous stent system in the treatment of iliac vein stenosis or occlusive lesions compare with conventional venous stent.
Interventions
DEVICEZylox Peripheral Venous Stent
Self-expanding stent implantation during the index procedure.
DEVICEZilver Vena Venous Stent
Self-expanding stent implantation during the index procedure.
Sponsors
Zhejiang Zylox Medical Device Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Aged from 18 to 75 years old, male or female * Subject's target lesions were stenosis and/or occlusion * CEAP≥C3 * Subjects were able to understand the purpose of the study, demonstrate full compliance with the program and sign informed consent
Exclusion criteria
* Pregnant woman or who's pregnancy test is positive * Lactation period woman or woman/man with fertility plan
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target vascular patency rate at 12 months after operation | 12 months | Target vascular patency rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of major adverse events | 12 months | Related to death of clinical trials |
| Adverse Event | Preoperative、Intraoperative、up to 1 month、3 month、6 month、12 month、2 years、3 years、5 years | Adverse medical events,whether or not related to the medical device |
Countries
China
Outcome results
None listed