Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT01120535
Status:
COMPLETED
Last Update Posted:
2014-06-30
First Post:
2010-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter 4
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011655', 'term': 'Pulmonary Embolism'}, {'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013923', 'term': 'Thromboembolism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016306', 'term': 'Vena Cava Filters'}], 'ancestors': [{'id': 'D057505', 'term': 'Embolic Protection Devices'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-26', 'studyFirstSubmitDate': '2010-05-06', 'studyFirstSubmitQcDate': '2010-05-10', 'lastUpdatePostDateStruct': {'date': '2014-06-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Success', 'timeFrame': '6 Months', 'description': 'Clinical Success is a composite endpoint consisting of technical success with freedom from pulmonary embolism, filter migration and device related events requiring intervention.'}], 'secondaryOutcomes': [{'measure': 'Rates of complications related to vena cava filter use.', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Vena Cava', 'Vena Cava Filter', 'Pulmonary Embolism', 'Venous Thromboembolism', 'Risk of Pulmonary Embolism'], 'conditions': ['Pulmonary Embolism']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/23622035', 'label': 'Smouse H, Mendes R, Bosiers M et al. The RETRIEVE Trial: Safety and Effectiveness of the Retrieval Crux Vena Cava Filter. JVIR 2013; 24:609-621.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the Crux Vena Cava Filter System is safe and effective in preventing pulmonary embolism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has a permanent or temporary risk of Pulmonary Embolism.\n* Patient must provide informed consent At least one of the following conditions -\n* Proven PE\n* Recurrent PE despite adequate\n* Contraindication to anticoagulation\n* Inability to achieve/maintain therapeutic anticoagulation\n* Iliocaval DVT\n* Large, free-floating proximal DVT\n* Massive PE treated with thrombolysis/thrombectomy\n* Chronic PE treated with thrombectomy\n* Protection during thrombolysis for iliocaval DVT\n* PE with limited cardiopulmonary reserve\n* Poor compliance with anticoagulation medication\n* High risk of injury worsening on anticoagulation\n* Multi-trauma patient with high risk of PE\n* Surgical patients at high risk of PE\n* Medical condition with high risk of PE Patients with a documented vena cava diameter of 17-28mm Patient has IVC anatomy suitable for infra-renal placement Patient is willing to be available for the appropriate follow up\n\nExclusion Criteria:\n\n* Age \\<18 years old\n* Patient has any one of the following conditions:\n\n * Renal vein thrombosis\n * IVC thrombosis extending to the renal veins\n * Duplicate IVC\n * Gonadal vein thrombosis\n * Requires supra-renal placement\n* Vena cava diameter of 17-28mm\n* Uncontrolled infectious disease\n* Risk of aseptic PE\n* Uncontrolled coagulopathy\n* Existing inferior vena cava filter implant\n* Life expectancy less than 6 months\n* Pregnant or planning a pregnancy in the next 6 months\n* Condition that inhibits radiographic visualization of the IVC\n* Known allergy or intolerance to polytetrafluoroethylene (PTFE) or Nitinol\n* Known hypersensitivity to contract which cannot be pretreated\n* Access vessels preclude same insertion of delivery system\n* Participation in another drug or device trial\n* Unable or unwilling to cooperate with study procedures or required follow-up visits'}, 'identificationModule': {'nctId': 'NCT01120535', 'acronym': 'RETRIEVE 4', 'briefTitle': 'Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter 4', 'organization': {'class': 'INDUSTRY', 'fullName': 'Crux Biomedical'}, 'officialTitle': 'Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 4 (RETRIEVE 4)', 'orgStudyIdInfo': {'id': 'Crux04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Crux Vena Cava Filter System', 'description': 'Subjects at risk for Pulmonary Embolism', 'interventionNames': ['Device: Inferior Vena Cava Filter']}], 'interventions': [{'name': 'Inferior Vena Cava Filter', 'type': 'DEVICE', 'description': 'Inplant of filter in inferior vena cava.', 'armGroupLabels': ['Crux Vena Cava Filter System']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brisbane', 'country': 'Australia', 'facility': 'Royal Brisbane Womens Hospital', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'city': 'Melbourne', 'country': 'Australia', 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland City Hospital', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Crux Biomedical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}