Iliac Vein StenosisNCT04812444
Peripheral Venous Stent System in the Treatment of Iliac Vein Stenosis or Occlusion
A study testing Zylox Peripheral Venous Stent and Zilver Vena Venous Stent in people with Iliac Vein Stenosis and Iliac Vein Occlusion, run by Zhejiang Zylox Medical Device Co., Ltd. at 1 site in China.
Trial summary
Clinical study on safety and efficacy of Zylox peripheral venous stent system in the treatment of iliac vein stenosis or occlusion. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Iliac Vein Stenosis, Iliac Vein Occlusion
- What is being tested?
- Zylox Peripheral Venous Stent and Zilver Vena Venous Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2020to 20 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant woman or who's pregnancy test is positive
- Lactation period woman or woman/man with fertility plan
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
About this study
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.
Clinical study on safety and efficacy of Zylox peripheral venous stent system in the treatment of iliac vein stenosis or occlusion.
Read the 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.
- Conditions
- Iliac Vein Stenosis, Iliac Vein Occlusion
- Being tested
- Zylox Peripheral Venous Stent, Zilver Vena Venous Stent
- Keywords
- Peripheral venous stent system, Iliac vein patency rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zylox Peripheral Venous StentDevice
Self-expanding stent implantation during the index procedure.
Zilver Vena Venous StentDevice
Self-expanding stent implantation during the index procedure.
| Study group | Role | What they receive |
|---|---|---|
| Zylox Peripheral Venous Stent Implantation | Experimental | Percutaneous stent placement in the iliofemoral veins Receives: Device: Zylox Peripheral Venous Stent |
| Zilver Vena Venous Stent Implantation | Active comparator | Percutaneous stent placement in the iliofemoral veins Receives: Device: Zilver Vena Venous Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target vascular patency rate at 12 months after operation
Target vascular patency rate
Measured: 12 months
Secondary outcomes (2)
The incidence of major adverse events
Related to death of clinical trials
Measured: 12 months
Adverse Event
Adverse medical events,whether or not related to the medical device
Measured: Preoperative、Intraoperative、up to 1 month、3 month、6 month、12 month、2 years、3 years、5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start9 Oct 2020
- Primary completion20 Oct 2023
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iliac Vein StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yu Zhao, Principal investigator, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812444
- Sponsor's protocol ID
- ZYLOX-02
- Status last verified
- Oct 2023
- First submitted
- 3 Nov 2020
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu H, Zeng Q, Li F, Wang X, Teng B, Zhao Y. Comparison of the Zylox Penguin Venous Stent System and Zilver Vena Stent for Non-thrombotic Iliac Vein Lesions: A Multicentre Randomised Controlled Trial. Eur J Vasc Endovasc Surg. 2026 Feb 25:S1078-5884(26)00198-X. doi: 10.1016/j.ejvs.2026.02.043. Online ahead of print.
PubMed 41759711
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04812444
- Acronym / sponsor ID
- ZYLOX-02
- Conditions
- Iliac Vein Stenosis, Iliac Vein Occlusion
- Keywords
- Peripheral venous stent system, Iliac vein patency rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Zhejiang Zylox Medical Device Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zylox Peripheral Venous Stent Implantation | Experimental | Device: Zylox Peripheral Venous StentPercutaneous stent placement in the iliofemoral veins |
| Zilver Vena Venous Stent Implantation | Active comparator | Device: Zilver Vena Venous StentPercutaneous stent placement in the iliofemoral veins |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnant woman or who's pregnancy test is positive
- Lactation period woman or woman/man with fertility plan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zylox Peripheral Venous StentSelf-expanding stent implantation during the index procedure. | Device | Zylox Peripheral Venous Stent Implantation |
| Zilver Vena Venous StentSelf-expanding stent implantation during the index procedure. | Device | Zilver Vena Venous Stent Implantation |
Primary outcome
Target vascular patency rate at 12 months after operation
Time frame: 12 months
Target vascular patency rate
2 secondary outcomes
The incidence of major adverse events
Time frame: 12 months
Adverse Event
Time frame: Preoperative、Intraoperative、up to 1 month、3 month、6 month、12 month、2 years、3 years、5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 41759711Liu H, Zeng Q, Li F, Wang X, Teng B, Zhao Y. Comparison of the Zylox Penguin Venous Stent System and Zilver Vena Stent for Non-thrombotic Iliac Vein Lesions: A Multicentre Randomised Controlled Trial. Eur J Vasc Endovasc Surg. 2026 Feb 25:S1078-5884(26)00198-X. doi: 10.1016/j.ejvs.2026.02.043. Online ahead of print.
Related trials for Iliac Vein Stenosis
Recruiting
Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting
Deep Vein Thrombosis, Iliac Vein Thrombosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Zhao principal investigator
First Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zylox Peripheral Venous Stent and Zilver Vena Venous Stent in people with Iliac Vein Stenosis and Iliac Vein Occlusion, run by Zhejiang Zylox Medical Device Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target vascular patency rate at 12 months after operation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04812444, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.