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

Iliac Vein Stenosis Clinical Trial

Official title:

Safety and Efficacy of Peripheral Venous Stent System in the Treatment of Patients With Iliac Vein Stenosis or Occlusion: a Prospective, Multicentre, Randomized Controlled Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04812444
• Other study ID #: ZYLOX-02
• Status: Completed
• Phase: N/A
• Start date: October 9, 2020
• Est. completion date: October 20, 2023

Study information

• Verified date: October 2023
• Source: Zhejiang Zylox Medical Device Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Clinical study on safety and efficacy of Zylox peripheral venous stent system in the treatment of iliac vein stenosis or occlusion.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: October 20, 2023
• Est. primary completion date: October 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Iliac Vein Occlusion
• Iliac Vein Stenosis

Intervention

Device:
• Zylox Peripheral Venous Stent
Self-expanding stent implantation during the index procedure.
• Zilver Vena Venous Stent
Self-expanding stent implantation during the index procedure.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Zylox Medical Device Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target vascular patency rate at 12 months after operation	Target vascular patency rate	12 months
Secondary	The incidence of major adverse events	Related to death of clinical trials	12 months
Secondary	Adverse Event	Adverse medical events,whether or not related to the medical device	Preoperative?Intraoperative?up to 1 month?3 month?6 month?12 month?2 years?3 years?5 years