Study of a Novel Thrombectomy Device to Treat Acute Iliofemoral Deep Venous Thrombosis

Study on the Application of a Novel Aspiration Thrombectomy Device Combined With Catheter-directed Thrombolysis for the Treatment of Acute Iliofemoral Deep Venous Thrombosis

The purpose of this study is to determine whether the novel aspiration thrombectomy device combined with catheter-directed thrombolysis is effective in the treatment of acute iliofemoral deep venous thrombosis (IF-DVT).

Catheter-directed thrombolysis will be performed in eligible patients with acute IF-DVT. A combined mechanical thrombectomy will be used to clear the iliac thrombi in experimental group. The immediate, mid- and long-term outcomes will be recorded. Quantitative data wiil be expressed as mean ± SD, and will be compared with independent-sample t-test or paired-sample t-test. Count data will be expressed as a ratio (or percentage), and the chi-square test or the fisher's exact test will be used for comparisons. A difference with P < 0.05 will be considered statistically significant. All statistical analyses will be performed using IBM SPSS, version 22.0 (SPSS Inc., Chicago, IL, USA).

A manual spiral thrombus broken suction device will be used for thrombectomy before catheter-directed thrombolysis. Ten million U of urokinase once every 4-6 hours will be used during catheter-directed thrombolysis therapy. Anticoagulation therapy will be administered via subcutaneous injection of low-molecular-weight heparin calcium (LMWH-Ca 5,000 U/12 h) at discharge

Participants will undergo catheter-directed thrombolysis alone. A total of 100,000 units urokinase will be pulse-spray injected through the catheter once every 4-6 h. Anticoagulation therapy will be administered via subcutaneous injection of low-molecular-weight heparin calcium (LMWH-Ca 5,000 U/12 h) at discharge

A manual spiral thrombus broken suction device will be used for thrombectomy before catheter-directed thrombolysis

anticoagulation therapy will be administered via subcutaneous injection of low-molecular-weight heparin calcium (LMWH-Ca 5,000 U/12 h) in both arms at discharge

A total of 100,000 units urokinase once every 4-6 hours will be used during catheter-directed thrombolysis therapy

participants will be followed for the duration of hospital stay and will be followed for up to 36 months by lower limb vein color Doppler ultrasonography

a composite outcome measure of observation of whether there is evidences of puncture site hematoma, vascular injury or vascular rupture

participants will be followed for the duration of hospital stay and will be followed for up to 36 months by clinical examinations

participants will be followed for up to 36 months to observe the incidence of postthrombotic syndrome which is associated with leg swelling, pain, ulceration

Inclusion Criteria: Clinical diagnosis of iliofemoral deep venous thrombosis Symptoms of less than 14 days' duration With good function status A life expectancy of more than 1 year A low risk of bleeding Exclusion Criteria: Without iliac vein thrombosis Anticoagulation and/or thrombolysis contraindications Systemic infection Heart, hepatic, renal function insufficiency

Department of Interventional Radiology and Vascular Surgery, the Affiliated Hospital of Xuzhou Medical College