Iliac Vein StenosisNCT05324787
Treatment of Vein Stenosis or Occlusion With the Oblique Stent
A study testing Grency venous stent system in people with Iliac Vein Stenosis and Iliac Vein Occlusion, run by Hangzhou Endonom Medtech Co., Ltd. at 2 sites in China.
Trial summary
To evaluate the safety and effectiveness of Grency venous stent system in the treatment of iliac vein stenosis or occlusion. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Iliac Vein Stenosis, Iliac Vein Occlusion
- What is being tested?
- Grency venous stent system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 2 sitesChina
- Study dates
- 22 Aug 2019to 9 Dec 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects aged 18-80 years;
- CEAP clinical grade C >=3;
- iliac vein stenosis >=50% or occlusion;
- patients voluntarily sign informed consent and complete follow-up.
Who cannot join
- subjects in pregnancy or lactation;
- renal insufficiency;
- subjects are allergic to contrast agents and anesthetics;
- subjects are allergic to nitinol;
- the life expectancy of cancer patients is less than 1 year;
- the length of the stent is expected to exceed the length of the inguinal ligament; 7. both sides of iliac vein stents were required;
- 8. long term bedridden or wheelchair patients; 9. the target vessel of the subject has been implanted into the iliac vein stent; 10. subjects have anticoagulant contraindications or are unable to receive long-term new oral anticoagulant therapy; 11. the investigator judged that the subjects had poor compliance and could not complete the clinical trial; 12. subjects are participating in clinical trials of other drugs or medical devices and have not yet completed the primary end point of the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Chinese People's Liberation Army General Hospital
Beijing
Zhongshan Hospital Affiliated to Fudan University
Shanghai
About this study
Official title: Single Arm, Multi-center Clinical Trial for the Safety and Effectiveness of Venous Stent System in the Treatment of Vein Stenosis or Occlusion
To evaluate the safety and effectiveness of Grency 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 effectiveness of a new dedicated venous stent system (Grency) in the treatment of iliac vein stenosis or occlusion. The Grency stent system has a hybrid oblique self-expanding design, which allows precise positioning at the iliocaval confluence.
- Conditions
- Iliac Vein Stenosis, Iliac Vein Occlusion
- Being tested
- Grency venous stent system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grency venous stent systemDevice
Venous stent implantation during the index procedure
| Study group | Role | What they receive |
|---|---|---|
| Grency venous stent system | Experimental | Not described Receives: Device: Grency venous stent system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patency rate of venous stent
Freedom from target vessel revascularization ; freedom from in-stent stenosis more than 50% by venography.
Measured: 12 months post-intervention
Secondary outcomes (4)
The rate of procedural technical success
Procedure technical success is defined as successful deployment of stent(s) to intended target without stent fracture or migration, as assessed by the investigator during the procedure.
Measured: During procedure
Change in the clinical symptoms
Change from baseline in the Venous Clinical Severity Score (VCSS) and Clinical-Etiologic-Anatomic-Pathophysiologic (CEAP) Classification at 3 months,6 months, and 12 months.
VCSS measures 10 clinical attributes of venous disease (Pain, Varicose Veins,Venous Edema, Skin Pigmentation, Inflammation, Induration, No. Active Ulcers, Active Ulcer Size, Ulcer Duration and Compression Therapy) on a scale of 0 - 3 (Absent 0, Mild 1, Moderate 2, and Severe 3).
Clinical-Etiologic-Anatomic-Pathophysiologic (CEAP) Classification is a system that describes a doctor's physical exam findings for vein problem(s), the cause of the problem(s), the location in the leg, and the mechanism responsible for the manifestation of the vein problem. For Clinicalclassification, the clinical components indicates disease severity, ranging from none (0 points) to active ulcers (6 points).
Measured: Baseline, 3 months,6 months, and12 months post-intervention
The rate of device related major adverse events(MAE)
Measured: 3,6,12 months post-intervention
The rate of adverse events (AE)
Measured: 3,6,12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start22 Aug 2019
- Primary completion9 Dec 2021
- Study completion9 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Endonom Medtech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324787
- Sponsor's protocol ID
- GR001
- Status last verified
- Apr 2022
- First submitted
- 31 Mar 2022
- Last updated
- 12 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm, Multi-center Clinical Trial for the Safety and Effectiveness of Venous Stent System in the Treatment of Vein Stenosis or Occlusion
- ClinicalTrials.gov ID
- NCT05324787
- Acronym / sponsor ID
- GR001
- Conditions
- Iliac Vein Stenosis, Iliac Vein Occlusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Hangzhou Endonom Medtech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 9 Dec 2021 (actual)
- Study completion
- 9 Dec 2021 (actual)
- First posted
- 12 Apr 2022 (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.
To evaluate the safety and effectiveness of Grency 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 effectiveness of a new dedicated venous stent system (Grency) in the treatment of iliac vein stenosis or occlusion. The Grency stent system has a hybrid oblique self-expanding design, which allows precise positioning at the iliocaval confluence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Grency venous stent system | Experimental | Device: Grency venous stent system |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- subjects aged 18-80 years;
- CEAP clinical grade C >=3;
- iliac vein stenosis >=50% or occlusion;
- patients voluntarily sign informed consent and complete follow-up.
Key exclusion criteria (7 listed)
- subjects in pregnancy or lactation;
- renal insufficiency;
- subjects are allergic to contrast agents and anesthetics;
- subjects are allergic to nitinol;
- the life expectancy of cancer patients is less than 1 year;
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 |
|---|---|---|
| Grency venous stent systemVenous stent implantation during the index procedure | Device | Grency venous stent system |
Primary outcome
Patency rate of venous stent
Time frame: 12 months post-intervention
Freedom from target vessel revascularization ; freedom from in-stent stenosis more than 50% by venography.
4 secondary outcomes
The rate of procedural technical success
Time frame: During procedure
Change in the clinical symptoms
Time frame: Baseline, 3 months,6 months, and12 months post-intervention
The rate of device related major adverse events(MAE)
Time frame: 3,6,12 months post-intervention
The rate of adverse events (AE)
Time frame: 3,6,12 months post-intervention
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 12 Apr 2022.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grency venous stent system in people with Iliac Vein Stenosis and Iliac Vein Occlusion, run by Hangzhou Endonom Medtech Co., Ltd. at 2 sites 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 7 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 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Patency rate of venous stent (time frame: 12 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2022; AzTrials last refreshed its copy on 8 Nov 2026.