Peripheral Venous Stent System in the Treatment of Iliac Vein Stenosis or Occlusion

Not Applicable

Completed

• Conditions: Iliac Vein Occlusion; Iliac Vein Stenosis
• Interventions: Device: Zylox Peripheral Venous Stent; Device: Zilver Vena Venous Stent

• Registration Number: NCT04812444
• Lead Sponsor: Zhejiang Zylox Medical Device Co., Ltd.

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.

Study Timeline

• Study Start: 2020-10-09
• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-23
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-19
• Primary Completion: 2023-10-20
• Study Completion: 2023-10-20
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zylox Peripheral Venous Stent Implantation	Zylox Peripheral Venous Stent	Percutaneous stent placement in the iliofemoral veins
Zilver Vena Venous Stent Implantation	Zilver Vena Venous Stent	Percutaneous stent placement in the iliofemoral veins

Primary Outcome Measures

Name	Time	Method
Target vascular patency rate at 12 months after operation	12 months	Target vascular patency rate

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China