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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
A manual spiral thrombus broken suction device will be used for thrombectomy before catheter-directed thrombolysis
catheter-directed thrombolysis will be used in both arms
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
Department of Interventional Radiology and Vascular Surgery, the Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, China
patency of lower extremity deep venous
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
Time frame: up to 36 months
technical success rate
The ratio of successful and total number of participants
Time frame: intraoperation
thrombus removal rate
The ratio of preoperative and postoperative thrombosis amount
Time frame: intraoperation
complications
a composite outcome measure of observation of whether there is evidences of puncture site hematoma, vascular injury or vascular rupture
Time frame: intraoperation
blood loss
The volume of blood loss during operation will be recorded
Time frame: intraoperation
improvement of clinical symptoms and signs
participants will be followed for the duration of hospital stay and will be followed for up to 36 months by clinical examinations
Time frame: up to 36 months
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A total of 100,000 units urokinase once every 4-6 hours will be used during catheter-directed thrombolysis therapy