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Single arm, multi-center clinical trial for the safety and effectiveness of venous stent system in the treatment of vein stenosis or occlusion

Single arm, multi-center clinical trial for the safety and effectiveness of venous stent system in the treatment of vein stenosis or occlusion

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032199
Enrollment
Unknown
Registered
2020-04-22
Start date
2019-08-20
Completion date
Unknown
Last updated
2020-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iliac vein stenosis or occlusion

Interventions

single arm:Iliac vein stent implantation

Sponsors

Chinese PLA General Hospital,Fudan University, Zhongshan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. subjects aged 18-80 years; 2. CEAP clinical grade C >=3; 3. iliac vein stenosis >=50% or occlusion; 4. patients voluntarily sign informed consent and complete follow-up.

Exclusion criteria

Exclusion criteria: 1. subjects in pregnancy or lactation; 2. renal insufficiency; 3. subjects are allergic to contrast agents and anesthetics; 4. subjects are allergic to nitinol; 5. the life expectancy of cancer patients is less than 1 year; 6. 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.

Design outcomes

Primary

MeasureTime frame
Patency rate of venous stent 12 months after operation;

Countries

China

Contacts

Public ContactZhang Meng-Sha

Hangzhou Weiqiang Medical Technology Co., Ltd.

mengsha.zhang@dnamedtech.com+86 15810134525

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026