NCT02414802.

Trial name or title	Study on the application of a novel aspiration thrombectomy device combined with catheter‐directed thrombolysis for the treatment of acute iliofemoral deep venous thrombosis
Methods	Study design: randomised, parallel assignment study
Participants	Setting: hospital Country: China Inclusion criteria: clinical diagnosis of iliofemoral deep venous thrombosis symptoms of less than 14 days' duration good function status a life expectancy of more than 1 year a low risk of bleeding Exclusion criteria: without iliac vein thrombosis anticoagulation or thrombolysis contraindications, or both systemic infection heart, hepatic, renal function insufficiency
Interventions	Intervention 1: combined thrombectomy device. A manual spiral thrombus broken suction device will be used for thrombectomy before catheter‐directed thrombolysis. Ten million U of urokinase once every 4 to 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 5000 U/12 h) at discharge Intervention 2: 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 to 6 hours. Anticoagulation therapy will be administered via subcutaneous injection of LMWH‐Ca 5000 U/12 h at discharge
Outcomes	Primary: patency of lower extremity deep venous system Secondary: technical success rate, thrombus removal rate, complications, blood loss, improvement of clinical symptoms and signs and incidence of post‐thrombotic syndrome
Starting date	December 2014
Contact information	Qingqiao Zhang, Xuzhou Medical College
Notes

LMWH‐Ca: low molecular weight heparin calcium