NCT07762222 Outcomes of Iliac Vein Stenting With Dedicated Venous Stents in Treatment of Chronic Post-thrombotic Venous Ulcers
| NCT ID | NCT07762222 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ain Shams University |
| Condition | Vascular |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-03-02 |
| Primary Completion | 2026-12-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-03-02 with a primary completion date of 2026-12-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
Inclusion Criteria: * Chronic non-healing venous ulcer associated with iliofemoral post-thrombotic syndrome. * CEAP clinical classification C6. * Iliofemoral post-thrombotic venous obstruction confirmed by appropriate venous imaging. * Age 18 years or older. * Ability to provide informed consent. Exclusion Criteria: * Nonthrombotic iliac vein lesion (NIVL). * Post-phlebitic femoropopliteal venous lesions with a patent iliac vein. * CEAP clinical classification other than C6. * Previous venous intervention. * Active pathological ulcer unrelated to post-thrombotic venous disease. * Life expectancy less than 2 years. * Pregnancy. * Known allergy to contrast media. * Contraindication to anesthesia. * Refusal to participate or inability to provide informed consent.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07762222 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Vascular. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07762222 currently recruiting?
Yes, NCT07762222 is actively recruiting participants. Contact the research team at postgrad@med.asu.edu.eg for enrollment information.
Where is the NCT07762222 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT07762222 clinical trial?
NCT07762222 is sponsored by Ain Shams University. The trial plans to enroll 20 participants.