Treatment of Vein Stenosis or Occlusion With the Oblique Stent

Not Applicable

Completed

• Conditions: Iliac Vein Occlusion; Iliac Vein Stenosis
• Interventions: Device: Grency venous stent system

• Registration Number: NCT05324787
• Lead Sponsor: Hangzhou Endonom Medtech Co., Ltd.

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 a hybrid oblique self-expanding design, which allows precise positioning at the iliocaval confluence.

Study Timeline

• Study Start: 2019-08-22
• Primary Completion: 2021-12-09
• Study Completion: 2021-12-09
• Study First Submitted: 2022-03-31
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-10
• Last Update Submitted: 2022-04-10
• Study First Posted: 2022-04-12
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Grency venous stent system	Grency venous stent system	-

Primary Outcome Measures

Name	Time	Method
Patency rate of venous stent	12 months post-intervention	Freedom from target vessel revascularization ; freedom from in-stent stenosis more than 50% by venography.

Secondary Outcome Measures

Name	Time	Method
Change in the clinical symptoms	Baseline, 3 months,6 months, and12 months post-intervention	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).
The rate of device related major adverse events(MAE)	3,6,12 months post-intervention
The rate of adverse events (AE)	3,6,12 months post-intervention
The rate of procedural technical success	During procedure	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.

Trial Locations

Locations (2)

Chinese People's Liberation Army General Hospital; 🇨🇳 Beijing, China

Zhongshan Hospital Affiliated to Fudan University; 🇨🇳 Shanghai, China