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

Zhejiang Zylox Medical Device

Status: Completed

Conditions: Iliac Vein Occlusion; Iliac Vein Stenosis

Treatments: Device: Zylox Peripheral Venous Stent; Device: Zilver Vena Venous Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT04812444

ZYLOX-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 220 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

220 participants in 2 patient groups

Zylox Peripheral Venous Stent Implantation

Experimental group

Description:

Percutaneous stent placement in the iliofemoral veins

Treatment:

Device: Zylox Peripheral Venous Stent

Zilver Vena Venous Stent Implantation

Active Comparator group

Description:

Percutaneous stent placement in the iliofemoral veins

Treatment:

Device: Zilver Vena Venous Stent