NCT07749820招募中不适用
A Prospective, Multicenter, Single-Arm Clinical Trial Evaluating the Safety and Efficacy of Thrombectomy Systems for the Treatment of Lower Extremity Deep Vein Thrombosis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- Technical success rate
研究概览
简要总结
This study plans to enroll 167 subjects. Subject enrollment and treatment details will be documented, and follow-up assessments will be conducted at screening, on the procedure day, before discharge, and at 1, 3, and 6 months after the procedure, to assess the safety and efficacy of the peripheral thrombectomy system for the treatment of lower extremity deep vein thrombosis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years；
- •Confirmed lower extremity deep vein thrombosis (DVT) by imaging, meeting at least one of the following: (1) acute iliofemoral or femoropopliteal DVT; or (2) subacute iliofemoral DVT;
- •Investigator-assessed life expectancy ≥1 year;
- •Willing to participate in this study and provide written informed consent.
排除标准
- •Infection at the puncture site or severe systemic infection;
- •Inability to establish vascular access or difficulty in advancing the guidewire through the lesion;
- •Hemodynamically unstable pulmonary embolism;
- •The target lesion thrombosis is recurrent after prior interventional therapy;
- •A venous stent has been implanted in the target lesion, or the presence of an inferior vena cava filter that interferes with device deployment;
- •Bilateral lower extremity deep vein thrombosis requiring thrombectomy in the same procedure;
- •Active bleeding within the past 30 days, including severe intracranial, gastrointestinal, or urinary tract bleeding;
- •History of hemorrhagic or ischemic stroke within the past 30 days;
- •Known severe coagulation disorder or bleeding tendency;
- •Severe hepatic or renal impairment;
- •Known allergy or significant hypersensitivity to iodine-based contrast media, thrombolytic agents, anticoagulants, or antiplatelet drugs;
- •Known conditions such as severe hyperthyroidism, multiple myeloma, or severe heart failure that preclude tolerance to percutaneous transluminal angioplasty;
- •Pregnant or lactating women, or women planning to become pregnant during the study period;
- •Currently participating in any other clinical trial of a drug or medical device;
- •Any other condition that, in the investigator's judgment, makes the subject ineligible for participation in this trial.
研究组 & 干预措施
Test group
Experimental
Thrombectomy system
干预措施: Peripheral thrombectomy system (Device)
结局指标
主要结局
Technical success rate
时间窗: Immediately after procedure, 0 day
≥50% thrombus removal in the target venous segment as assessed by venography.
次要结局
- Major adverse events (MAE) rate(30 days)
- Device success rate(Immediately after procedure, 0 day)
- Vein Patency(at 6 months)
- Incidence of PTS(at 6 Months)
- AE and SAE(Up to 6 months)
- VCSS score(Baseline, 1 Month, 6 Months)
研究者
研究点 (1)
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