Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-02-24 @ 11:15 AM
Study NCT ID:
NCT02414802
Status:
UNKNOWN
Last Update Posted:
2017-01-18
First Post:
2015-03-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of a Novel Thrombectomy Device to Treat Acute Iliofemoral Deep Venous Thrombosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2018-02-20', 'unreleaseDateUnknown': True}, {'releaseDate': '2018-02-21', 'unreleaseDate': '2018-08-12'}, {'resetDate': '2019-01-25', 'releaseDate': '2018-08-12'}], 'estimatedResultsFirstSubmitDate': '2018-02-20'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}, {'id': 'D014568', 'term': 'Urokinase-Type Plasminogen Activator'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D010960', 'term': 'Plasminogen Activators'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-15', 'studyFirstSubmitDate': '2015-03-25', 'studyFirstSubmitQcDate': '2015-04-07', 'lastUpdatePostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'incidence of postthrombotic syndrome', 'timeFrame': 'up to 36 months', 'description': 'participants will be followed for up to 36 months to observe the incidence of postthrombotic syndrome which is associated with leg swelling, pain, ulceration'}], 'primaryOutcomes': [{'measure': 'patency of lower extremity deep venous', 'timeFrame': 'up to 36 months', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'technical success rate', 'timeFrame': 'intraoperation', 'description': 'The ratio of successful and total number of participants'}, {'measure': 'thrombus removal rate', 'timeFrame': 'intraoperation', 'description': 'The ratio of preoperative and postoperative thrombosis amount'}, {'measure': 'complications', 'timeFrame': 'intraoperation', 'description': 'a composite outcome measure of observation of whether there is evidences of puncture site hematoma, vascular injury or vascular rupture'}, {'measure': 'blood loss', 'timeFrame': 'intraoperation', 'description': 'The volume of blood loss during operation will be recorded'}, {'measure': 'improvement of clinical symptoms and signs', 'timeFrame': 'up to 36 months', 'description': 'participants will be followed for the duration of hospital stay and will be followed for up to 36 months by clinical examinations'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Venous Thrombosis']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': "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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of iliofemoral deep venous thrombosis\n* Symptoms of less than 14 days' duration\n* With good function status\n* A life expectancy of more than 1 year\n* A low risk of bleeding\n\nExclusion Criteria:\n\n* Without iliac vein thrombosis\n* Anticoagulation and/or thrombolysis contraindications\n* Systemic infection\n* Heart, hepatic, renal function insufficiency"}, 'identificationModule': {'nctId': 'NCT02414802', 'briefTitle': 'Study of a Novel Thrombectomy Device to Treat Acute Iliofemoral Deep Venous Thrombosis', 'organization': {'class': 'OTHER', 'fullName': 'Xuzhou Medical University'}, 'officialTitle': 'Study on the Application of a Novel Aspiration Thrombectomy Device Combined With Catheter-directed Thrombolysis for the Treatment of Acute Iliofemoral Deep Venous Thrombosis', 'orgStudyIdInfo': {'id': 'BL2014030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combined thrombectomy device', 'description': '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', 'interventionNames': ['Device: a manual spiral thrombus broken suction device', 'Procedure: catheter-directed thrombolysis', 'Drug: low-molecular-weight heparin calcium', 'Drug: urokinase']}, {'type': 'OTHER', 'label': 'Catheter-directed thrombolysis', 'description': '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', 'interventionNames': ['Procedure: catheter-directed thrombolysis', 'Drug: low-molecular-weight heparin calcium', 'Drug: urokinase']}], 'interventions': [{'name': 'a manual spiral thrombus broken suction device', 'type': 'DEVICE', 'description': 'A manual spiral thrombus broken suction device will be used for thrombectomy before catheter-directed thrombolysis', 'armGroupLabels': ['Combined thrombectomy device']}, {'name': 'catheter-directed thrombolysis', 'type': 'PROCEDURE', 'description': 'catheter-directed thrombolysis will be used in both arms', 'armGroupLabels': ['Catheter-directed thrombolysis', 'Combined thrombectomy device']}, {'name': 'low-molecular-weight heparin calcium', 'type': 'DRUG', 'otherNames': ['Low-Molecular-Weight Heparin Calcium for Injection'], 'description': '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', 'armGroupLabels': ['Catheter-directed thrombolysis', 'Combined thrombectomy device']}, {'name': 'urokinase', 'type': 'DRUG', 'otherNames': ['Urokinase for Injection'], 'description': 'A total of 100,000 units urokinase once every 4-6 hours will be used during catheter-directed thrombolysis therapy', 'armGroupLabels': ['Catheter-directed thrombolysis', 'Combined thrombectomy device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '221006', 'city': 'Xuzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Department of Interventional Radiology and Vascular Surgery, the Affiliated Hospital of Xuzhou Medical College', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}], 'overallOfficials': [{'name': 'Qingqiao Zhang, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Xuzhou Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'postgraduate student', 'investigatorFullName': 'Qianxin Huang', 'investigatorAffiliation': 'Xuzhou Medical University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-02-20', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2018-02-21', 'type': 'RELEASE'}, {'date': '2018-08-12', 'type': 'UNRELEASE'}, {'date': '2018-08-12', 'type': 'RELEASE'}, {'date': '2019-01-25', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Qianxin Huang, postgraduate student, Xuzhou Medical University'}}}}