Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-02-25 @ 9:49 PM
Study NCT ID:
NCT01404403
Status:
COMPLETED
Last Update Posted:
2013-11-05
First Post:
2011-07-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of the Rapid System for Acute Ischemic Stroke
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-04', 'studyFirstSubmitDate': '2011-07-26', 'studyFirstSubmitQcDate': '2011-07-26', 'lastUpdatePostDateStruct': {'date': '2013-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants with Adverse Device Effects (ADEs) Percentage of participants with Adverse Device Effects (ADEs)Percentage', 'timeFrame': '12 patients'}]}, 'conditionsModule': {'conditions': ['Acute Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'This is a safety study of the Rapid System for acute ischemic stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥18 to \\<85 years old\n* Pre stroke modified Rankin Scale (mRS) of ≤2\n* A signed informed consent by patient or a legally acceptable representative\n\nExclusion Criteria:\n\n* Pre-stroke life expectancy of less than 6 months\n* Current participation in another investigational drug or device study\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01404403', 'briefTitle': 'Safety Study of the Rapid System for Acute Ischemic Stroke', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rapid Medical'}, 'orgStudyIdInfo': {'id': '002-07-01-RR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Stroke patients', 'interventionNames': ['Device: Rapid System']}], 'interventions': [{'name': 'Rapid System', 'type': 'DEVICE', 'armGroupLabels': ['Stroke patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '171 76', 'city': 'Stockholm', 'state': 'Solna', 'country': 'Sweden', 'facility': 'Karolinska Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rapid Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}