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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Venous Thrombosis

Intervention / Treatment
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* Device: a manual spiral thrombus broken suction device
* Procedure: catheter-directed thrombolysis
* Drug: low-molecular-weight heparin calcium
* Drug: urokinase


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined thrombectomy device<br>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 | Device: a manual spiral thrombus broken suction device<br>* A manual spiral thrombus broken suction device will be used for thrombectomy before catheter-directed thrombolysis<br>Procedure: catheter-directed thrombolysis<br>* catheter-directed thrombolysis will be used in both arms<br>Drug: low-molecular-weight heparin calcium<br>* 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<br>* Other names: Low-Molecular-Weight Heparin Calcium for Injection;Drug: urokinase<br>* A total of 100,000 units urokinase once every 4-6 hours will be used during catheter-directed thrombolysis therapy<br>* Other names: Urokinase for Injection;|
| Other: Catheter-directed thrombolysis<br>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 | Procedure: catheter-directed thrombolysis<br>* catheter-directed thrombolysis will be used in both arms<br>Drug: low-molecular-weight heparin calcium<br>* 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<br>* Other names: Low-Molecular-Weight Heparin Calcium for Injection;Drug: urokinase<br>* A total of 100,000 units urokinase once every 4-6 hours will be used during catheter-directed thrombolysis therapy<br>* Other names: Urokinase for Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| technical success rate | The ratio of successful and total number of participants | intraoperation | 
| thrombus removal rate | The ratio of preoperative and postoperative thrombosis amount | intraoperation | 
| complications | a composite outcome measure of observation of whether there is evidences of puncture site hematoma, vascular injury or vascular rupture | intraoperation | 
| blood loss | The volume of blood loss during operation will be recorded | 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 | up to 36 months |