Outcomes of Iliac Vein Stenting With Dedicated Venous Stents in Treatment of Chronic Post-thrombotic Venous Ulcers

Summary

Outcomes of iliac vein stenting with dedicated venous stents in treatment of chronic post-thrombotic venous ulcers Deep vein thrombosis (DVT) affects 1 to 3 individuals per 1000 annually. Among these patients, 20% to 50% may develop post-thrombotic syndrome (PTS), with the likelihood varying based on the extent and location of the thrombus. Notably, despite receiving anticoagulation therapy, 5% to 10% of patients may progress to severe PTS, potentially leading to the development of venous ulcers (Afsha Aurshina, 2018). Chronic venous obstruction (CVO) refers to the impediment of venous flow, typically resulting from either partial or complete blockage of the venous system. This obstruction leads to diminished venous flow and elevated pressure within the affected veins. CVO serves as a broad descriptor for various conditions, including post-thrombotic syndrome (PTS) and nonthrombotic iliac vein lesions (NIVLs). PTS commonly arises as a complication of deep vein thrombosis (DVT), with estimates indicating that up to 50% of patients diagnosed with iliofemoral DVT will develop PTS within two years following their initial diagnosis. (Mohammad E. Barbati, 2024)

The study aims to know the outcomes of iliac vein stenting with dedicated venous stenting in the treatment of post-thrombotic syndrome venous ulcer.

Type of Study: Prospective single arm cohort study

* Study Setting: Ain Shams University hospitals
* Study Period: 2 years with 6 months follow up
* Sample Size: 20 patients.
* Study Population Patients presenting to the outpatient clinic at Ain Shams University Hospitals with venous ulcers.
* Study Tools

* 20 patients will be selected.
* Written informed consent.
* Full history taking, personal history , risk factors of DVT, presence of any medical illness , assessment of QOL based on CVIQ 20 - questionnaire, list of symptoms, sensations or types of discomfort that you may or may not be experiencing and which may make everyday life hard to bear to a greater or lesser extent.
* Clinical evaluation: based on revised Venous Clinical Severity Score rVCSS , Villalta score and CEAP classification . rVCSS includes 10 items, such as pain, varicose veins, oedema, skin pigmentation, inflammation, skin induration, number of active ulcers, ulcer size, duration of ulcer, and application of pressure therapy. Each item is scored from 0 to 3 according to the severity, and the total score is 30. A higher score indicates higher severity. And using villlata score It can be used to both diagnose and categories the severity of the condition. The Villalta score involves both the patient who grades the presence and severity (0-3 points) of five symptoms ( pain , cramps, heaviness, parasthesia and pruritus ) and and the physician who grades six clinical signs(Pre-tibial oedema, Hyper-pigmentation, Redness, Venous Ectasia, ain on calf compression, ulcers) (0-3 points) after examination of the lower limb. Also the clinical severity of the venous disease will be graded according to the clinical, etiological, anatomical, and pathophysiological (CEAP) scoring system, and assessment of venous ulcer assessment (by onset, course, duration, site, size, shape

Conditions

• Vascular
• DVT - Deep Vein Thrombosis
• Post Thrombotic Syndrome
• Venous Ulcer of Leg

Interventions

PROCEDURE

dedicated venous stenting

iliofemoral dedicated venous stenting

DEVICE

Dedicated venous stent / iliofemoral dedicated venous stenting

Participants with chronic non-healing venous ulcers associated with iliofemoral post-thrombotic syndrome will undergo iliofemoral venous balloon venoplasty and dedicated venous stenting in addition to standard venous ulcer care and compression therapy.

Sponsors & Collaborators

• Ain Shams University

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-02

Primary Completion

2026-12-02

Completion

2027-01-01

FDA Device

Yes

Countries

• Egypt

Study Locations