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Clinical study on safety and efficacy of Zylox peripheral venous stent system in the treatment of iliac vein stenosis or occlusion.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zylox Peripheral Venous Stent Implantation | Experimental | Percutaneous stent placement in the iliofemoral veins |
|
| Zilver Vena Venous Stent Implantation | Active Comparator | Percutaneous stent placement in the iliofemoral veins |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zylox Peripheral Venous Stent | Device | Self-expanding stent implantation during the index procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target vascular patency rate at 12 months after operation | Target vascular patency rate | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of major adverse events | Related to death of clinical trials | 12 months |
| Adverse Event | Adverse medical events,whether or not related to the medical device |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yu Zhao | First Affiliated Hospital of Chongqing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41759711 | Derived | Liu H, Zeng Q, Li F, Wang X, Teng B, Zhao Y. Comparison of the Zylox Penguin Venous Stent System and Zilver Vena Stent for Non-thrombotic Iliac Vein Lesions: A Multicentre Randomised Controlled Trial. Eur J Vasc Endovasc Surg. 2026 Feb 25:S1078-5884(26)00198-X. doi: 10.1016/j.ejvs.2026.02.043. Online ahead of print. |
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| Zilver Vena Venous Stent | Device | Self-expanding stent implantation during the index procedure. |
|
| Preoperative、Intraoperative、up to 1 month、3 month、6 month、12 month、2 years、3 years、5 years |