Treatment of Vein Stenosis or Occlusion With the Oblique Stent

NCT ID: NCT05324787

Last Updated: 2022-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-22
• Study Completion Date: 2021-12-09

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.

Conditions

Iliac Vein Stenosis; Iliac Vein Occlusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Grency venous stent system

Group Type: EXPERIMENTAL

Grency venous stent system

Intervention Type: DEVICE

Venous stent implantation during the index procedure

Interventions

Grency venous stent system

Venous stent implantation during the index procedure

Intervention Type: DEVICE

Eligibility 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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hangzhou Endonom Medtech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chinese People's Liberation Army General Hospital

Beijing, , China

Zhongshan Hospital Affiliated to Fudan University

Shanghai, , China

Countries

China

Other Identifiers

GR001

Identifier Type: -

Identifier Source: org_study_id