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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined thrombectomy device | Experimental | 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 | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| a manual spiral thrombus broken suction device | Device | A manual spiral thrombus broken suction device will be used for thrombectomy before catheter-directed thrombolysis |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of postthrombotic syndrome | participants will be followed for up to 36 months to observe the incidence of postthrombotic syndrome which is associated with leg swelling, pain, ulceration | up to 36 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qingqiao Zhang, PHD | Xuzhou Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Interventional Radiology and Vascular Surgery, the Affiliated Hospital of Xuzhou Medical College | Xuzhou | Jiangsu | 221006 | China |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 20, 2018 | |
| Unrelease | Yes | |
| Release | Feb 21, 2018 | |
| Unrelease | Aug 12, 2018 | |
| Release | Aug 12, 2018 | |
| Reset | Jan 25, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 20, 2018 | Yes | |||
| Feb 21, 2018 | Aug 12, 2018 |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D007267 | Injections |
| D014568 | Urokinase-Type Plasminogen Activator |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D012697 | Serine Endopeptidases |
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| catheter-directed thrombolysis | Procedure | catheter-directed thrombolysis will be used in both arms |
|
| low-molecular-weight heparin calcium | Drug | 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 | Drug | A total of 100,000 units urokinase once every 4-6 hours will be used during catheter-directed thrombolysis therapy |
|
|
| 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 |
| Aug 12, 2018 | Jan 25, 2019 |
| D010450 |
| Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |