Status:
COMPLETED
Treatment of Vein Stenosis or Occlusion With the Oblique Stent
Lead Sponsor:
Hangzhou Endonom Medtech Co., Ltd.
Conditions:
Iliac Vein Stenosis
Iliac Vein Occlusion
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2021
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT05324787
Start Date
August 22 2019
End Date
December 9 2021
Last Update
April 12 2022
Active Locations (2)
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1
Chinese People's Liberation Army General Hospital
Beijing, China
2
Zhongshan Hospital Affiliated to Fudan University
Shanghai, China