Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT04479020
Status:
COMPLETED
Last Update Posted:
2024-12-06
First Post:
2020-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
REcanalization of Distal Cerebral Vessels in Acute Stroke Using ApeRio®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2020-07-02', 'studyFirstSubmitQcDate': '2020-07-16', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary efficacy endpoint', 'timeFrame': 'Immediatley after interventional procedure', 'description': 'Successful arterial recanalization of occluded target vessel measured by mTICI score of 2b or 3 following the use of the APERIO® and APERIO® Hybrid(17) Thrombectomy Device without any symptomatic intracranial hemorrhage and rescue therapy within 3 passes per Device mTICI describes the response of thrombolytic therapy in ischemic stroke. Higashida et al. 2003: Grade 0: no perfusion Grade 1: penetration with minimal perfusion Grade 2: partial perfusion Grade 2A: only partial filling (less than two-thirds) of the entire vascular territory is visualized Grade 2B: complete filling of all of the expected vascular territory is visualized but the filling is slower than normal Grade 3: complete perfusion'}, {'measure': 'Primary safety endpoint', 'timeFrame': '48 hours', 'description': '• Symptomatic intracranial hemorrhage (sICH): ICH in periprocedural (\\<48 hours) CT associated with worsening of NIHSS by ≥ 4 points within 48 hours.'}, {'measure': 'Primary safety endpoint', 'timeFrame': '90 days', 'description': 'Rates of device and procedure related (serious) adverse events ((S)AEs)'}, {'measure': 'Primary Safety endpoint', 'timeFrame': '90 days', 'description': 'Mortality'}], 'secondaryOutcomes': [{'measure': 'Good neurological outcome', 'timeFrame': '90 days', 'description': 'mRS (modified Ranking Scale)= 0-2\n\n0 No Symptoms\n\n1. No significant disability, despite symptoms, able to perform all usual duties and activities\n2. Slight disability; unable to perform all previous activities but able to look after own affairs without assistance\n3. Moderate disability; requires some help, but able to walk without assistance\n4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance\n5. Severe disability bedridden incontinent and requires constant nursing care and attention\n6. Patient died'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Stroke']}, 'descriptionModule': {'briefSummary': 'The purpose of the REVISAR PMCF is to collect data in clinical practice of the APERIO® and APERIO® Hybrid(17) Thrombectomy Device, which are intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Recanalization status will be assessed at the end of the procedure using the modified TICI (Thrombolysis in cerebral infarction) score.', 'detailedDescription': 'Study Type: prospective, multicenter, single-arm, open-label, national\n\nParticipants: 11 participating centers in Germany\n\nPI: Dr. Franziska Dorn, University Hospital Bonn, Germany\n\nEstimated Enrolment: A minimum of 130 patients treated with the APERIO® or APERIO® Hybrid(17) Thrombectomy Device due to thrombotic occlusions in a distal vessel of the anterior and posterior circulation (postbifurcal MCA, ACA, PCA)\n\nFollow up: 3 months\n\nEstimated Final Assessment: End of 2022\n\nThis is a prospective, multicenter, single-arm, open-label, national Post-Market Clinical Follow-up Study to collect comprehensive information on technical and clinical success and safety of the use of APERIO® and APERIO® Hybrid(17) Thrombectomy Device in a distal vessel of the anterior and posterior circulation (postbifurcal MCA, ACA, PCA). Aperio® and Aperio® Hybrid(17) Thrombectomy Device will be used within its approved indication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with an APERIO® or APERIO® Hybrid(17) Thrombectomy Device due to a thrombotic occlusion in distal vessel of the anterior and posterior circulation (postbifurcal MCA, ACA, PCA).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient treated with the APERIO® or APERIO® Hybrid(17) Thrombectomy Device due to occlusion in distal vessel of the anterior and posterior circulation (postbifurcal MCA, ACA, PCA) according to IFU\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* pre stroke mRS ≥ 3\n* Any contraindication according to IFU'}, 'identificationModule': {'nctId': 'NCT04479020', 'briefTitle': 'REcanalization of Distal Cerebral Vessels in Acute Stroke Using ApeRio®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Acandis GmbH'}, 'officialTitle': 'REcanalization of Distal Cerebral Vessels in Acute Stroke Using ApeRio®', 'orgStudyIdInfo': {'id': 'REVISAR Revision 4.0'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Mechanical Thrombectomy', 'type': 'DEVICE', 'description': 'Mechanical thrombectomy requiring the use an APERIO® or APERIO® Hybrid(17) Thrombectomy device due to an thrombotic occlusion in a distal vessel of the anterior and posterior circulation (postbifurcal MCA, ACA, PCA)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Schlosspark Klinik Charlottenburg', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '53127', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Universitätsklinikum Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Cologne', 'country': 'Germany', 'facility': 'Universitätsklinikum Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Universitätsklinikum Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Fulda', 'country': 'Germany', 'facility': 'Klinikum Fulda gAG', 'geoPoint': {'lat': 50.55162, 'lon': 9.67518}}, {'city': 'Göttingen', 'country': 'Germany', 'facility': 'Universitätsmedizin Göttingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'city': 'Homburg', 'country': 'Germany', 'facility': 'Universitätsklinikum des Saarlandes', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}, {'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Magdeburg A. ö. R.', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'city': 'Minden', 'country': 'Germany', 'facility': 'Johannes Wesling Klinikum Minden', 'geoPoint': {'lat': 52.28953, 'lon': 8.91455}}, {'zip': '80336', 'city': 'München', 'country': 'Germany', 'facility': 'Klinikum der Universität München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '42697', 'city': 'Solingen', 'country': 'Germany', 'facility': 'radprax Neurozentrum Solingen', 'geoPoint': {'lat': 51.17343, 'lon': 7.0845}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acandis GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}