Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-01 @ 8:56 PM
Study NCT ID:
NCT04466033
Status:
COMPLETED
Last Update Posted:
2025-05-07
First Post:
2020-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Safety and Performance of Magneto Microcatheter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2020-07-05', 'studyFirstSubmitQcDate': '2020-07-09', 'lastUpdatePostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the safety of Magneto Microcatheter in the acute post procedure duration by assessing the incidence of device related Serious Adverse Events within 24 hours post procedure', 'timeFrame': '24 hours', 'description': 'Occurrence of device related Serious Adverse Events'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the safety of Magneto Microcatheter by assessing the incidence of device related Serious Adverse Events within 90 days post procedure', 'timeFrame': '90 days', 'description': 'Occurrence of device related Serious Adverse Events'}, {'measure': 'Evaluation of the performance of Magneto Microcatheter by assessing its ability to remove the clot and evaluating its ease of use', 'timeFrame': 'During Procedure', 'description': 'Assessment of device performance in clot removal (TICI scale to evaluate revascularization) and ease of use (questionnaire that will be completed by the treating physician post procedure)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'A prospective, open label single arm feasibility study to evaluate the safety and performance of the Magneto Microcatheter in patients diagnosed with acute ischemic stroke and planned for thrombectomy procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Clinical signs consistent with acute ischemic stroke\n2. Patient with Acute Ischemic Stroke within 24 hours from symptoms o\n3. Age 18-85 years old\n4. Consent process is completed per international and local regulations\n\nExclusion Criteria:\n\n1. Known use of cocaine or other vasoactive substance\n2. Known bleeding diathesis\n3. Any known hemorrhagic or coagulation deficiency.\n4. Current use of oral anticoagulants with International Normalized Ratio (INR) \\> 3;\n5. PTT (Partial Thromboplastin Time)\\>2 at screening\n6. Uncontrolled hypertension (Systolic blood pressure\\>185 or Diastolic blood pressure\\>110) refractory to pharmacological management\n7. Pregnant or lactating female\n8. CT scan or MRI with evidence of acute intracranial hemorrhage, ASPECT score\\<6, mass effect and/or intracranial tumor\n9. Angiographic evidence of either carotid dissection or vasculitis at the target site or any condition that may limit device access to the target site (i.e high grade stenosis) per the treating physician's discretion."}, 'identificationModule': {'nctId': 'NCT04466033', 'briefTitle': 'Evaluation of the Safety and Performance of Magneto Microcatheter', 'organization': {'class': 'INDUSTRY', 'fullName': 'Magneto Thrombectomy Solutions'}, 'officialTitle': 'Evaluation of the Safety and Performance of Magneto Microcatheter for Endovascular Thrombectomy in Patients With Acute Ischemic Stroke', 'orgStudyIdInfo': {'id': 'C14-CLN002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Magneto Microcatheter', 'interventionNames': ['Device: Magneto Microcatheter']}], 'interventions': [{'name': 'Magneto Microcatheter', 'type': 'DEVICE', 'description': 'All patients will be treated with Magneto Microcatheter', 'armGroupLabels': ['Magneto Microcatheter']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Budapest', 'country': 'Hungary', 'facility': 'National Institute of Mental Health, Neurology and Neurosurgery)', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Shaare Zedek', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'overallOfficials': [{'name': 'Dr. Marzelik', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}, {'name': 'Dr.Amsalem', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shaare Zedek, Israel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Magneto Thrombectomy Solutions', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}