Treatment of Vein Stenosis or Occlusion With the Oblique Stent

Hangzhou Endonom Medtech

Status: Completed

Conditions: Iliac Vein Occlusion; Iliac Vein Stenosis

Treatments: Device: Grency venous stent system

Study type: Interventional

Funder types: Industry

Identifiers

NCT05324787

GR001

Details and patient eligibility

About

To evaluate the safety and effectiveness of Grency venous stent system in the treatment of iliac vein stenosis or occlusion.

Full 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.

Enrollment: 112 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

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;

7. 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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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112 participants in 1 patient group

Grency venous stent system

Experimental group

Treatment:

Device: Grency venous stent system