NCT04812444

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2020

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

3 years

First QC Date

November 3, 2020

Last Update Submit

October 19, 2023

Conditions

Iliac Vein StenosisIliac Vein Occlusion

Keywords

Peripheral venous stent systemIliac vein patency rate

Outcome Measures

Primary Outcomes (1)

  • Target vascular patency rate at 12 months after operation

    Target vascular patency rate

    12 months

Secondary Outcomes (2)

  • The incidence of major adverse events

    12 months

  • Adverse Event

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

Study Arms (2)

Zylox Peripheral Venous Stent Implantation

EXPERIMENTAL

Percutaneous stent placement in the iliofemoral veins

Device: Zylox Peripheral Venous Stent

Zilver Vena Venous Stent Implantation

ACTIVE COMPARATOR

Percutaneous stent placement in the iliofemoral veins

Device: Zilver Vena Venous Stent

Interventions

Zylox Peripheral Venous StentDEVICE

Self-expanding stent implantation during the index procedure.

Zylox Peripheral Venous Stent Implantation
Zilver Vena Venous StentDEVICE

Self-expanding stent implantation during the index procedure.

Zilver Vena Venous Stent Implantation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant woman or who's pregnancy test is positive
  • Lactation period woman or woman/man with fertility plan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

Study Officials

  • Yu Zhao

    First Affiliated Hospital of Chongqing Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2020

First Posted

March 23, 2021

Study Start

October 9, 2020

Primary Completion

October 20, 2023

Study Completion

October 20, 2023

Last Updated

October 23, 2023

Record last verified: 2023-10

Locations

CN(1)