Treatment of Vein Stenosis or Occlusion With the Oblique Stent

Iliac Vein Stenosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05324787
• Other study ID #: GR001
• Status: Completed
• Phase: N/A
• Start date: August 22, 2019
• Est. completion date: December 9, 2021

Study information

• Verified date: April 2022
• Source: Hangzhou Endonom Medtech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 9, 2021
• Est. primary completion date: December 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Iliac Vein Occlusion
• Iliac Vein Stenosis

Intervention

Device:
• Grency venous stent system
Venous stent implantation during the index procedure

Locations

Country	Name	City	State
China	Chinese People's Liberation Army General Hospital	Beijing
China	Zhongshan Hospital Affiliated to Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Endonom Medtech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patency rate of venous stent	Freedom from target vessel revascularization ; freedom from in-stent stenosis more than 50% by venography.	12 months post-intervention
Secondary	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.	During procedure
Secondary	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).	Baseline, 3 months,6 months, and12 months post-intervention
Secondary	The rate of device related major adverse events(MAE)		3,6,12 months post-intervention
Secondary	The rate of adverse events (AE)		3,6,12 months post-intervention