Treatment of Vein Stenosis or Occlusion With the Oblique Stent

NCT05324787 | Completed

• 1 other identifier: GR001
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Iliac Vein Stenosis; Iliac Vein Occlusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The rate of procedural technical success

  During procedure

• Change in the clinical symptoms

  Baseline, 3 months,6 months, and12 months post-intervention

• 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

Study Arms (1)

Grency venous stent system

EXPERIMENTAL

Device: Grency venous stent system

Interventions

Grency venous stent system DEVICE

Venous stent implantation during the index procedure

Grency venous stent system

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• \. 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.

Sponsors & Collaborators

• Hangzhou Endonom Medtech Co., Ltd.: lead

Study Sites (2)

Chinese People's Liberation Army General Hospital

Beijing, China

Location

Zhongshan Hospital Affiliated to Fudan University

Shanghai, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 12, 2022
• Study Start: August 22, 2019
• Primary Completion: December 9, 2021
• Study Completion: December 9, 2021
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)