Study of a Novel Thrombectomy Device to Treat Acute Iliofemoral Deep Venous Thrombosis
NCT ID: NCT02414802
Last Updated: 2017-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2014-12-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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 4-6 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
a manual spiral thrombus broken suction device
A manual spiral thrombus broken suction device will be used for thrombectomy before catheter-directed thrombolysis
catheter-directed thrombolysis
catheter-directed thrombolysis will be used in both arms
low-molecular-weight heparin calcium
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
urokinase
A total of 100,000 units urokinase once every 4-6 hours will be used during catheter-directed thrombolysis therapy
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
catheter-directed thrombolysis will be used in both arms
low-molecular-weight heparin calcium
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
urokinase
A total of 100,000 units urokinase once every 4-6 hours will be used during catheter-directed thrombolysis therapy
Interventions
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a manual spiral thrombus broken suction device
A manual spiral thrombus broken suction device will be used for thrombectomy before catheter-directed thrombolysis
catheter-directed thrombolysis
catheter-directed thrombolysis will be used in both arms
low-molecular-weight heparin calcium
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
urokinase
A total of 100,000 units urokinase once every 4-6 hours will be used during catheter-directed thrombolysis therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Anticoagulation and/or thrombolysis contraindications
* Systemic infection
* Heart, hepatic, renal function insufficiency
18 Years
75 Years
ALL
No
Sponsors
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Xuzhou Medical University
OTHER
Responsible Party
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Qianxin Huang
postgraduate student
Principal Investigators
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Qingqiao Zhang, PHD
Role: STUDY_DIRECTOR
Xuzhou Medical University
Locations
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Department of Interventional Radiology and Vascular Surgery, the Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, China
Countries
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Other Identifiers
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BL2014030
Identifier Type: -
Identifier Source: org_study_id
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