Outcomes of Iliac Vein Stenting With Dedicated Venous Stents in Treatment of Chronic Post-thrombotic Venous Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- complete healing of venous ulcer
研究概览
简要总结
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
详细描述
Study Procedures and Interventions:
All participants will receive standardized venous ulcer care, including wound assessment, appropriate dressing according to the amount of exudate, and elastic compression using class II elastic stockings. Wound care will be provided twice weekly in the vascular surgery clinic by the study investigators. Debridement and wound culture with sensitivity testing will be performed when clinically indicated.
Participants assigned to the interventional treatment will undergo endovascular iliac venous recanalization and stenting. The ipsilateral great saphenous vein, popliteal vein, or femoral vein will be used as the preferred venous access according to the anatomical characteristics of each case. Procedures will be performed under ultrasound guidance.
After venous access, an antegrade venogram will be obtained to assess the venous anatomy and determine the location and extent of iliac venous obstruction. A guidewire will be advanced across the obstructed segment, followed by balloon venoplasty using an appropriately sized balloon. A dedicated self-expanding venous stent will then be deployed across the obstructed segment. Stent diameter will be selected according to the venous anatomy and vessel dimensions, with adequate post-dilatation when required. Completion venography will be performed to assess the final venous flow and stent position.
Following the procedure, venous access sites will be compressed with a sterile dressing. Antithrombotic treatment will be administered according to the study protocol. Low-molecular-weight heparin will be administered at a dose of 5000 IU every 12 hours after stent implantation, followed by therapeutic anticoagulation with warfarin targeting an international normalized ratio of 2-3 or rivaroxaban 20 mg once daily for at least 1 year after hospital discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic non-healing venous ulcer associated with iliofemoral post-thrombotic syndrome.
- •CEAP clinical classification C
- •Iliofemoral post-thrombotic venous obstruction confirmed by appropriate venous imaging.
- •Age 18 years or older.
- •Ability to provide informed consent.
排除标准
- •Nonthrombotic iliac vein lesion (NIVL).
- •Post-phlebitic femoropopliteal venous lesions with a patent iliac vein.
- •CEAP clinical classification other than C
- •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.
研究组 & 干预措施
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.
干预措施: Dedicated venous stent / iliofemoral dedicated venous stenting (Device)
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.
干预措施: dedicated venous stenting (Procedure)
结局指标
主要结局
complete healing of venous ulcer
时间窗: 12 months
Proportion of participants with complete healing of the venous ulcer at 12 months after iliofemoral venous stenting.
次要结局
- Time to complete venous ulcer healing(12 months)
- Change in rVCSS(12 months)
- Venous ulcer recurrence(12 months)