Vascular Surgery Department of Beijing Tsinghua ChangGung Hospital
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
研究概览
简要总结
This trial is a prospective, multicenter, randomized controlled, superiority study. According to the inclusion and exclusion criteria for clinical research subjects, 104 patients with acute deep vein thrombosis involving the iliac and femoral veins were recruited. Qualified subjects were randomly (1:1) assigned to either the experimental group or the control group. The experimental group received thrombus aspiration, with or without balloon dilation, stent implantation, and other accompanying surgical treatments, combined with standard anticoagulant therapy, while the control group received only standard anticoagulant therapy. The efficacy and safety of the experimental group in treating acute iliac and femoral vein thrombosis were compared. The main efficacy endpoint of this study is the 24 month postoperative composite endpoint, with the following hierarchical order: 1. in-hospital mortality or treatment upgrade; 2. Recurrent venous thrombosis or newly developed pulmonary embolism of the target lesion within 24 months; 3. Severity of Villalta score at 24 months; 4. Change in VEINES score after 24 months. Simultaneously observe other secondary efficacy endpoints and safety endpoints. Clinical follow-up was conducted before discharge, 30 days after surgery, 6 months after surgery, 12 months after surgery, and 24 months after surgery.
详细描述
This is a prospective, multicenter, randomized controlled, superiority clinical trial. A total of 104 patients with acute or subacute iliofemoral deep vein thrombosis (DVT) are planned to be enrolled. Participants will receive either thrombus aspiration combined with standard anticoagulant therapy or standard anticoagulant monotherapy according to the randomization principle. The trial aims to verify the efficacy and safety of thrombus aspiration plus standard anticoagulant therapy versus standard anticoagulant therapy alone in the treatment of acute or subacute iliofemoral deep vein thrombosis.
Clinical follow-up assessments will be conducted at pre-discharge, 30 days, 6 months, 12 months, and 24 months after the procedure.
The hierarchical composite endpoint at 24 months post-procedure is defined as the primary efficacy endpoint.
Secondary efficacy endpoints include: immediate post-procedure thrombus clearance success rate (intervention group only), 30-day thrombus recurrence rate, Villalta score, VEINES-QOL/Sym quality of life questionnaire for venous insufficiency, and concomitant treatment (excluding treatment escalation).
Secondary safety endpoints include: major bleeding events within 30 days post-procedure, serious adverse events related to aspiration therapy and concomitant endovascular therapy, and serious adverse events other than major bleeding associated with anticoagulant therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80, gender unrestricted;
- •Diagnosed as acute or subacute proximal deep venous thrombosis of the lower extremities through lower extremity venous ultrasound or enhanced CT of the lower extremity veins, with involvement of at least the common iliac vein, external iliac vein, or common femoral vein;
- •The subjects met the criteria for standard anticoagulation therapy combined with thrombus aspiration along with standard anticoagulation therapy;
- •The patient fully understands and voluntarily signs a written informed consent form;
- •Willing and able to comply with all the visit, treatment, and assessment procedures specified in the study protocol.
排除标准
- •Bilateral deep iliofemoral vein thrombosis;
- •Femoral edema or femoral white swelling;
- •Inferior vena cava thrombosis;
- •History of deep vein thrombosis with a diagnosis of moderate to severe post-thrombotic syndrome;
- •The affected limb has previously had a venous stent implanted;
- •There are anatomical abnormalities affecting the intervention pathway, such as hypoplasia or dysplasia of the inferior vena cava, or other malformations of the iliac or inferior vena cava;
- •Presence of active major bleeding or clinically significant bleeding risk (hemoglobin <80g/L or platelet count <50×109/L);
- •Severe coagulation dysfunction, with an international normalized ratio >1.7;
- •Uncontrolled severe hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >105 mmHg after medication);
- •Severe renal impairment, with a glomerular filtration rate <30 mL/min/1.73m²;
- •Any interventional treatment for the target deep vein thrombosis within 30 days prior to enrollment;
- •Female patients in pregnancy or lactation;
- •Known history of allergies to drugs used during the study (such as contrast agents, anticoagulants, etc.);
- •Active malignant tumor;
- •In the judgment of the researchers, there are any other comorbidities, conditions, or poor adherence that may affect the study evaluation or place the patient at high risk.
研究者
Weiwei Wu
Chief of Vascular Surgery Department
Beijing Tsinghua Chang Gung Hospital