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Completed

NCT Number: NCT05324787

Treatment of Vein Stenosis or Occlusion With the Oblique Stent

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

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Key information

Conditions

Iliac Vein Stenosis Iliac Vein Occlusion

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese People's Liberation Army General Hospital, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • 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.

Treatment and study plan

Grency venous stent system

Device

Venous stent implantation during the index procedure

Primary outcomes

  1. Patency rate of venous stent

    Time frame: 12 months post-intervention

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

Secondary outcomes

  1. The rate of procedural technical success

    Time frame: During procedure

    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.

  2. Change in the clinical symptoms

    Time frame: Baseline, 3 months,6 months, and12 months post-intervention

    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).

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

    Time frame: 3,6,12 months post-intervention

  4. The rate of adverse events (AE)

    Time frame: 3,6,12 months post-intervention

Sponsors and collaborators

Lead sponsor

Hangzhou Endonom Medtech Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 12, 2022
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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