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NCT Number: NCT04812444

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

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

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Key information

Conditions

Iliac Vein Stenosis Iliac Vein Occlusion

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zylox Peripheral Venous Stent

Device

Self-expanding stent implantation during the index procedure.

Zilver Vena Venous Stent

Device

Self-expanding stent implantation during the index procedure.

Primary outcomes

  1. Target vascular patency rate at 12 months after operation

    Time frame: 12 months

    Target vascular patency rate

Secondary outcomes

  1. The incidence of major adverse events

    Time frame: 12 months

    Related to death of clinical trials

  2. Adverse Event

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Zhejiang Zylox Medical Device Co., Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 23, 2021
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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