Thrombectomy system to treat leg DVT

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study will enroll up to 167 adults with confirmed lower extremity DVT at risk of complications. Participants will undergo thrombectomy with a peripheral thrombectomy system and be followed at screening, the procedure day, discharge, and at 1, 3, and 6 months to monitor safety and efficacy. Data will include procedural details and follow-up outcomes to assess device performance in reducing clot burden and preventing adverse events. The trial is interventional and does not specify a fixed phase. Enrollment is limited to centers capable of vascular access and device deployment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zhongshan Hospital, Fudan University
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Fu, PhD
• Email: fu.weiguo@zs-hospital.sh.cn
• Phone: 021-31587871

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.