A Multicenter, Randomized, Positive-controlled Clinical Trial to Verify the Efficacy and Safety of the SaExten Vena Cava Filter System in Prevention of Pulmonary Embolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 16
- 主要终点
- Clinical success rate of IVCF implantation
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of SaExten vena cava filter (VCF) system (ShenZhen KYD BioTech Co., Ltd., China) in prevention of pulmonary embolism (PE).
This is a prospective, multicenter, randomized controlled, positive-controlled clinical trial, which will enroll 204 participants in total. Participants will undergo interventions with SaExten VCF System or Denali filter (C. R. BARD, Inc., USA).
详细描述
The purpose of this study is to evaluate the efficacy and safety of SaExten vena cava filter (VCF) system in prevention of pulmonary embolism (PE).
This is a prospective, multicenter, randomized controlled, positive-controlled clinical trial, which will enroll 204 participants in total, with 102 in each group. Participants will undergo interventions with SaExten VCF System or Denali filter, and be followed up to 12 months if the implantation is permanent, to evaluate the efficacy and safety of SaExten VCF System in prevention of PE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old and life expectancy ≥ 12 months;
- •The diameter of inferior vena cava is between 18.0mm and 26.0mm;
- •Patients with acute (≤14 days of onset) proximal (inferior lumen, iliac, femoral, popliteal vein) deep vein thrombosis (DVT), or at risk of pulmonary embolism (PE) caused by thrombus detoxification, with or without symptoms of pulmonary embolism;
- •People at risk of pulmonary embolism (PE) meet at least one of the following conditions:
- •Patients with acute DVT who plan to undergo catheter-directed thrombolysis (CDT), percutaneous mechanical thrombectomy (PMT) or surgical thrombectomy;
- •Patients who have failed anticoagulant therapy, have recurrent PE and/or DVT, and have contraindications to anticoagulant therapy or are at serious risk of bleeding;
- •Floating thrombus in iliac, femoral vein or inferior vena cava;
- •Patients with high risk factors for acute DVT and PE who underwent abdominal, pelvic or lower limb surgery;
- •Patients with DVT who have already developed a large area of PE and are at risk of developing PE again;
- •DVT accompanied by serious heart and lung disease, pulmonary hypertension;
- •Severe injuries (such as hip fracture, etc.), accompanied by vascular endothelial injury, accompanied by blood hypercoagulability and anticoagulant therapy contraindications;
- •Those who can understand the purpose of the trial, cooperate with the follow-up, and sign the informed consent voluntarily.
排除标准
- •Patients with severe stenosis or deformity of the inferior vena cava or severe spinal deformity;
- •Patients with uncontrolled infectious diseases, purulent embolism or fat embolism;
- •Previous vena cava filter implantation history;
- •Thrombosis in the venous access required for the filter implantation;
- •Patients with severe liver and renal dysfunction (ALT>3 times the upper limit of normal; Creatinine>225umol/L);
- •Patients with known uncorrectable bleeding or severe coagulation disease;
- •Patients who are allergic to contrast agents, nickel and have contraindication to X-ray;
- •With disease causing difficulties in treatment and evaluation (such as septicemia, bacteremia, toxemia, severe metabolic disease, cancer metastasis, mental illness, etc.);
- •Malignant tumor patients;
- •Pregnant and lactating women, or those who is planning parenthood;
- •Participated in clinical trials of other drugs or medical devices before inclusion and haven't reach the end point time limit;
- •Persons considered by the investigator to be unsuitable for participation in this clinical trial.
结局指标
主要结局
Clinical success rate of IVCF implantation
时间窗: 6 months
Clinical success requires the following three factors: * No clinical symptomatic pulmonary embolism occurred within 6 months after long-term filter implantation, which was confirmed by CT pulmonary angiography (CTPA); No clinical pulmonary embolism occurred between the time of filter implantation and the time of filter retrieval, which was confirmed by pulmonary angiography. * The IVCF was successfully implanted with satisfactory shape and position; * No filter fracture, no displacement over 20 mm , no inclination (\> 15°) during implantation/retrieval, no IVC penetration, no thrombosis of the IVC, and no implant-related or operation-related deaths.
次要结局
- Technical success rate of IVCF implantation(1 day)
- Clinical success rate of IVCF retrieval(90 days)
- Technical success rate of IVCF retrieval(90 days)
- Evaluation of operation performance of filter and transporting system(90 days)
- The combined incidence of filter displacement over 20 mm, fracture, tilt (> 15°) and IVC penetration within 6 months after implantation(6 months)
- Incidence of pulmonary embolism within 6 months after implantation.(6 months)
- The incidence of new or aggravated deep vein thrombosis within 6 months after implantation(6 months)
- The incidence of compound clinical events of pulmonary embolism, IVC thrombosis, death, and recurrent deep venous thrombosis of lower limbs at 30 days, 3 months, and 6 months after vena cava filter implantation(30 days, 3 months, and 6 months)
- The number of days from implantation to retrieval (for patients whose filters have been retrieved)(90 days)