Iliac Vein Occlusion, Iliac Vein Stenosis
Conditions
Brief summary
To evaluate the safety and effectiveness of Grency 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 effectiveness of a new dedicated venous stent system (Grency) in the treatment of iliac vein stenosis or occlusion. The Grency stent system has a hybrid oblique self-expanding design, which allows precise positioning at the iliocaval confluence.
Interventions
DEVICEGrency venous stent system
Venous stent implantation during the index procedure
Sponsors
Hangzhou Endonom Medtech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. subjects aged 18-80 years; 2. CEAP clinical grade C \>=3; 3. iliac vein stenosis \>=50% or occlusion; 4. patients voluntarily sign informed consent and complete follow-up.
Exclusion criteria
1. subjects in pregnancy or lactation; 2. renal insufficiency; 3. subjects are allergic to contrast agents and anesthetics; 4. subjects are allergic to nitinol; 5. the life expectancy of cancer patients is less than 1 year; 6. the length of the stent is expected to exceed the length of the inguinal ligament; 7. both sides of iliac vein stents were required; 8\. long term bedridden or wheelchair patients; 9. the target vessel of the subject has been implanted into the iliac vein stent; 10. subjects have anticoagulant contraindications or are unable to receive long-term new oral anticoagulant therapy; 11. the investigator judged that the subjects had poor compliance and could not complete the clinical trial; 12. subjects are participating in clinical trials of other drugs or medical devices and have not yet completed the primary end point of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patency rate of venous stent | 12 months post-intervention | Freedom from target vessel revascularization ; freedom from in-stent stenosis more than 50% by venography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The rate of procedural technical success | During procedure | Procedure technical success is defined as successful deployment of stent(s) to intended target without stent fracture or migration, as assessed by the investigator during the procedure. |
| Change in the clinical symptoms | Baseline, 3 months,6 months, and12 months post-intervention | Change from baseline in the Venous Clinical Severity Score (VCSS) and Clinical-Etiologic-Anatomic-Pathophysiologic (CEAP) Classification at 3 months,6 months, and 12 months. VCSS measures 10 clinical attributes of venous disease (Pain, Varicose Veins,Venous Edema, Skin Pigmentation, Inflammation, Induration, No. Active Ulcers, Active Ulcer Size, Ulcer Duration and Compression Therapy) on a scale of 0 - 3 (Absent 0, Mild 1, Moderate 2, and Severe 3). Clinical-Etiologic-Anatomic-Pathophysiologic (CEAP) Classification is a system that describes a doctor's physical exam findings for vein problem(s), the cause of the problem(s), the location in the leg, and the mechanism responsible for the manifestation of the vein problem. For Clinicalclassification, the clinical components indicates disease severity, ranging from none (0 points) to active ulcers (6 points). |
| The rate of device related major adverse events(MAE) | 3,6,12 months post-intervention | — |
| The rate of adverse events (AE) | 3,6,12 months post-intervention | — |
Countries
China
Outcome results
None listed