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.
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Eligibility Criteria
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 …
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.
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