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

NCT ID: NCT04812444

Last Updated: 2023-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-09

Study Completion Date

2023-10-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Iliac Vein Stenosis Iliac Vein Occlusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Zylox Peripheral Venous Stent Implantation

Percutaneous stent placement in the iliofemoral veins

Group Type EXPERIMENTAL

Zylox Peripheral Venous Stent

Intervention Type DEVICE

Self-expanding stent implantation during the index procedure.

Zilver Vena Venous Stent Implantation

Percutaneous stent placement in the iliofemoral veins

Group Type ACTIVE_COMPARATOR

Zilver Vena Venous Stent

Intervention Type DEVICE

Self-expanding stent implantation during the index procedure.

Interventions

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Zylox Peripheral Venous Stent

Self-expanding stent implantation during the index procedure.

Intervention Type DEVICE

Zilver Vena Venous Stent

Self-expanding stent implantation during the index procedure.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Zylox Medical Device Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yu Zhao

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Chongqing Medical University

Locations

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The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

Other Identifiers

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ZYLOX-02

Identifier Type: -

Identifier Source: org_study_id

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