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

Zhejiang Zylox Medical Device Co., Ltd.220 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

220

Conditions

Iliac Vein Stenosis Iliac Vein Occlusion

Interventions

Zylox Peripheral Venous StentDEVICE

Self-expanding stent implantation during the index procedure.

Zilver Vena Venous StentDEVICE

Self-expanding stent implantation during the index procedure.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Outcomes

Primary Outcomes

Target vascular patency rate at 12 months after operation

Target vascular patency rate

Time frame: 12 months

Secondary Outcomes

The incidence of major adverse events

Related to death of clinical trials

Time frame: 12 months

Adverse Event

Adverse medical events,whether or not related to the medical device

Time frame: Preoperative、Intraoperative、up to 1 month、3 month、6 month、12 month、2 years、3 years、5 years

Data from ClinicalTrials.gov

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