Overview
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.
Eligibility
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.
