Study of a Novel Thrombectomy Device to Treat Acute Iliofemoral Deep Venous Thrombosis
- Conditions
- Venous Thrombosis
- Interventions
- Device: a manual spiral thrombus broken suction deviceProcedure: catheter-directed thrombolysis
- Registration Number
- NCT02414802
- Lead Sponsor
- Xuzhou Medical University
- Brief Summary
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).
- Detailed Description
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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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
- Without iliac vein thrombosis
- Anticoagulation and/or thrombolysis contraindications
- Systemic infection
- Heart, hepatic, renal function insufficiency
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combined thrombectomy device a manual spiral thrombus broken suction device A manual spiral thrombus broken suction device will be used for thrombectomy before catheter-directed thrombolysis. Ten million U of urokinase once every 4-6 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 Combined thrombectomy device catheter-directed thrombolysis 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 Catheter-directed thrombolysis catheter-directed thrombolysis 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 Catheter-directed thrombolysis low-molecular-weight heparin calcium 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 Combined thrombectomy device low-molecular-weight heparin calcium 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 Catheter-directed thrombolysis urokinase 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 Combined thrombectomy device urokinase 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
- Primary Outcome Measures
Name Time Method patency of lower extremity deep venous up to 36 months 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
- Secondary Outcome Measures
Name Time Method technical success rate intraoperation The ratio of successful and total number of participants
thrombus removal rate intraoperation The ratio of preoperative and postoperative thrombosis amount
complications intraoperation a composite outcome measure of observation of whether there is evidences of puncture site hematoma, vascular injury or vascular rupture
blood loss intraoperation The volume of blood loss during operation will be recorded
improvement of clinical symptoms and signs up to 36 months participants will be followed for the duration of hospital stay and will be followed for up to 36 months by clinical examinations
Trial Locations
- Locations (1)
Department of Interventional Radiology and Vascular Surgery, the Affiliated Hospital of Xuzhou Medical College
🇨🇳Xuzhou, Jiangsu, China