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

Primary Purpose

Iliac Vein Stenosis, Iliac Vein Occlusion

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Zylox Peripheral Venous Stent
Zilver Vena Venous Stent
Sponsored by
Zhejiang Zylox Medical Device Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iliac Vein Stenosis focused on measuring Peripheral venous stent system, Iliac vein patency rate

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The First Affiliated Hospital of Chongqing Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Zylox Peripheral Venous Stent Implantation

Zilver Vena Venous Stent Implantation

Arm Description

Percutaneous stent placement in the iliofemoral veins

Percutaneous stent placement in the iliofemoral veins

Outcomes

Primary Outcome Measures

Target vascular patency rate at 12 months after operation
Target vascular patency rate

Secondary Outcome Measures

The incidence of major adverse events
Related to death of clinical trials
Adverse Event
Adverse medical events,whether or not related to the medical device

Full Information

First Posted
November 3, 2020
Last Updated
October 19, 2023
Sponsor
Zhejiang Zylox Medical Device Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04812444
Brief Title
Peripheral Venous Stent System in the Treatment of Iliac Vein Stenosis or Occlusion
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 9, 2020 (Actual)
Primary Completion Date
October 20, 2023 (Actual)
Study Completion Date
October 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Zylox Medical Device Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iliac Vein Stenosis, Iliac Vein Occlusion
Keywords
Peripheral venous stent system, Iliac vein patency rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zylox Peripheral Venous Stent Implantation
Arm Type
Experimental
Arm Description
Percutaneous stent placement in the iliofemoral veins
Arm Title
Zilver Vena Venous Stent Implantation
Arm Type
Active Comparator
Arm Description
Percutaneous stent placement in the iliofemoral veins
Intervention Type
Device
Intervention Name(s)
Zylox Peripheral Venous Stent
Intervention Description
Self-expanding stent implantation during the index procedure.
Intervention Type
Device
Intervention Name(s)
Zilver Vena Venous Stent
Intervention Description
Self-expanding stent implantation during the index procedure.
Primary Outcome Measure Information:
Title
Target vascular patency rate at 12 months after operation
Description
Target vascular patency rate
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The incidence of major adverse events
Description
Related to death of clinical trials
Time Frame
12 months
Title
Adverse Event
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Zhao
Organizational Affiliation
First Affiliated Hospital of Chongqing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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