Clinical Trial of Thrombectomy Systems

Inclusion criteria

• 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.

Exclusion criteria

• 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.