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Treatment of Vein Stenosis or Occlusion With the Oblique Stent

Primary Purpose

Iliac Vein Stenosis, Iliac Vein Occlusion

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Grency venous stent system
Sponsored by
Hangzhou Endonom Medtech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iliac Vein Stenosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chinese People's Liberation Army General Hospital
  • Zhongshan Hospital Affiliated to Fudan University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Grency venous stent system

Arm Description

Outcomes

Primary Outcome Measures

Patency rate of venous stent
Freedom from target vessel revascularization ; freedom from in-stent stenosis more than 50% by venography.

Secondary Outcome Measures

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.
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).
The rate of device related major adverse events(MAE)
The rate of adverse events (AE)

Full Information

First Posted
March 31, 2022
Last Updated
April 10, 2022
Sponsor
Hangzhou Endonom Medtech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05324787
Brief Title
Treatment of Vein Stenosis or Occlusion With the Oblique Stent
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 22, 2019 (Actual)
Primary Completion Date
December 9, 2021 (Actual)
Study Completion Date
December 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hangzhou Endonom Medtech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iliac Vein Stenosis, Iliac Vein Occlusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Grency venous stent system
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Grency venous stent system
Intervention Description
Venous stent implantation during the index procedure
Primary Outcome Measure Information:
Title
Patency rate of venous stent
Description
Freedom from target vessel revascularization ; freedom from in-stent stenosis more than 50% by venography.
Time Frame
12 months post-intervention
Secondary Outcome Measure Information:
Title
The rate of procedural technical success
Description
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.
Time Frame
During procedure
Title
Change in the clinical symptoms
Description
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).
Time Frame
Baseline, 3 months,6 months, and12 months post-intervention
Title
The rate of device related major adverse events(MAE)
Time Frame
3,6,12 months post-intervention
Title
The rate of adverse events (AE)
Time Frame
3,6,12 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; 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.
Facility Information:
Facility Name
Chinese People's Liberation Army General Hospital
City
Beijing
Country
China
Facility Name
Zhongshan Hospital Affiliated to Fudan University
City
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment of Vein Stenosis or Occlusion With the Oblique Stent

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