Treatment of Vein Stenosis or Occlusion With the Oblique Stent

Single Arm, Multi-center Clinical Trial for the Safety and Effectiveness of Venous Stent System in the Treatment of Vein Stenosis or Occlusion

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

Study Overview

• Status: Completed
• Conditions: Iliac Vein Stenosis; Iliac Vein Occlusion
• Intervention / Treatment: Device: Grency venous stent system

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 Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Chinese People's Liberation Army General Hospital
  • Shanghai, China
    • Zhongshan Hospital Affiliated to Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Grency venous stent system	Device: Grency venous stent system; Venous stent implantation during the index procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Hangzhou Endonom Medtech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2019
• Primary Completion (Actual): December 9, 2021
• Study Completion (Actual): December 9, 2021

Study Registration Dates

• First Submitted: March 31, 2022
• First Submitted That Met QC Criteria: April 10, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 10, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: GR001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No