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

October 19, 2023 updated by: Zhejiang Zylox Medical Device Co., Ltd.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China
        • The First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zylox Peripheral Venous Stent Implantation
Percutaneous stent placement in the iliofemoral veins
Device: Zylox Peripheral Venous Stent
Self-expanding stent implantation during the index procedure.
Active Comparator: Zilver Vena Venous Stent Implantation
Percutaneous stent placement in the iliofemoral veins
Device: Zilver Vena Venous Stent
Self-expanding stent implantation during the index procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target vascular patency rate at 12 months after operation
Time Frame: 12 months
Target vascular patency rate
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of major adverse events
Time Frame: 12 months
Related to death of clinical trials
12 months
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
Preoperative、Intraoperative、up to 1 month、3 month、6 month、12 month、2 years、3 years、5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Zylox Medical Device Co., Ltd.

Investigators

  • Principal Investigator: Yu Zhao, First Affiliated Hospital of Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2020

Primary Completion (Actual)

October 20, 2023

Study Completion (Actual)

October 20, 2023

Study Registration Dates

First Submitted

November 3, 2020

First Submitted That Met QC Criteria

March 22, 2021

First Posted (Actual)

March 23, 2021

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZYLOX-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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