Ignite Creation Date:
2025-12-24 @ 12:55 PM
Ignite Modification Date:
2026-02-22 @ 9:37 AM
Study NCT ID:
NCT02186561
Status:
COMPLETED
Last Update Posted:
2019-12-27
First Post:
2014-07-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prospective Study on Embolization of Intracranial Aneurysms With Pipeline™ Embolization Device
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002532', 'term': 'Intracranial Aneurysm'}], 'ancestors': [{'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'darren.j.lacour@medtronic.com', 'phone': '949-680-1274', 'title': 'Senior Project Manager, Clinical Project Management', 'organization': 'Medtronic Neurovascular, Clinical Affairs'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected from the point of consent through year 3', 'description': "The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated.\n\nAdjudicable events met the following criteria:\n\n* All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events)\n* All Device Related Adverse Events\n* All Procedure Related Adverse Events\n* All Serious Adverse Events (SAE's)", 'eventGroups': [{'id': 'EG000', 'title': 'CEC Adjudicated Adverse Events Through 1-Year', 'description': 'Participants who received the Investigational Device followed through 1 Year', 'otherNumAtRisk': 141, 'deathsNumAtRisk': 141, 'otherNumAffected': 107, 'seriousNumAtRisk': 141, 'deathsNumAffected': 1, 'seriousNumAffected': 39}, {'id': 'EG001', 'title': 'CEC Adjudicated Adverse Events Through 2-Year', 'description': 'Participants who received the Investigational Device followed through 2 Year', 'otherNumAtRisk': 141, 'deathsNumAtRisk': 141, 'otherNumAffected': 112, 'seriousNumAtRisk': 141, 'deathsNumAffected': 1, 'seriousNumAffected': 49}, {'id': 'EG002', 'title': 'CEC Adjudicated Adverse Events Through 3-Year', 'description': 'Participants who received the Investigational Device followed through 3 Year', 'otherNumAtRisk': 141, 'deathsNumAtRisk': 141, 'otherNumAffected': 112, 'seriousNumAtRisk': 141, 'deathsNumAffected': 2, 'seriousNumAffected': 60}], 'otherEvents': [{'term': 'Haemorrhagic Diathesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Lymphoid tissue hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Amaurosis Fugax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Blepharospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Conjunctival Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Photopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Vitreous detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Gastrointestinal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Catheter site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Catheter site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Local swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Catheter site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Periorbital Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Vascular pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hypervolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Spinal Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Carpal Tunnel Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cerebral vasoconstriction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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{'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '135', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Intent to Treat Population was defined as all enrolled participants in whom deployment of the Investigational device was attempted.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-03-24', 'size': 1710980, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-01T20:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 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Percentage of Participants With the Occurrence of Major Stroke in the Territory Supplied by the Treated Artery or Neurological Death at 12-Months Post Procedure', 'timeFrame': 'Up to 12 Months Post Procedure', 'description': 'The primary safety endpoint was defined as a stroke which results in focal neurological deficit for 24 hrs or more and increases the NIH Stroke Scale of the subject by ≥ 4 along with an imaging correlate. Missing data for subjects who failed to complete the 12- month post-procedure evaluation without any evidence of a major stroke in the territory supplied by the treated artery or neurological death were imputed in the analysis using multiple imputation. Multiple imputation provides a mechanism for deriving estimates for a population where not all of the patients have an endpoint determination.'}, {'measure': 'The Percentage of Participants With Complete Aneurysm Occlusion (Defined as Raymond Roy Grade 1) Without Significant Parent Artery Stenosis (≤ 50%) or Retreatment of the Target Aneurysm at 12-Months Post-Procedure', 'timeFrame': 'Up to 12 Months Post Procedure', 'description': 'The definitions for the three components of the primary effectiveness endpoint were: 1) retreatment, defined as all retreatment procedures occurring between the index procedure and 1 Year post-procedure; 2) complete aneurysm occlusion based on Core Laboratory review of 1-year images and 3) significant parent artery stenosis, based on Core Laboratory review of 1-year images. The Raymond-Roy Grading scale is used for judging intracranial aneurysm (IA) endosaccular embolization success. Grade I is completion occlusion with no flow of contrast seen in the aneurysm sac, Grade II is partial occlusion with some flow or eddy flow in the aneurysm sac and Grade III is residual aneurysm or Incomplete occlusion with apparent flow in the aneurysm sac.\n\nMultiple imputation provides a mechanism for deriving estimates for a population where not all of the patients have an endpoint determination.'}], 'secondaryOutcomes': [{'measure': 'The Number of Participants With a Major Stroke in the Territory Supplied by the Treated Artery or Neurological Death at 30-days Post Procedure Due to Procedural Complications', 'timeFrame': 'Up to 30 days, Post Procedure', 'description': 'Major Stroke is defined as a stroke which results in focal neurological deficit for 24 hrs or more and increases the NIH Stroke Scale of the subject by ≥ 4 along with an imaging correlate. Neurological death is any subject death due to neurologic reasons.'}, {'measure': 'The Number of Participants Who Experienced Delayed Intracerebral Hemorrhage > 30 Days Post-Procedure', 'timeFrame': '> 30 days, Post Procedure', 'description': 'For the purpose of this protocol, delayed intracerebral hemorrhage was defined as hemorrhage within the fixed vault of the cranium (skull) occurring greater than 30 days post-procedure.'}, {'measure': 'The Number of Participants With Successfully Deployed Investigational Device', 'timeFrame': 'Index Procedure', 'description': 'The secondary outcome measures provides the number of participants successfully implanted with the Investigational device during the study index procedure at the target site.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Intracranial aneurysm', 'brain aneurysm'], 'conditions': ['Intracranial Aneurysm']}, 'referencesModule': {'references': [{'pmid': '39357888', 'type': 'DERIVED', 'citation': 'Rodriguez-Erazu F, Cortez GM, Lopes DK, Gutierrez-Aguirre SF, De Toledo OF, Aghaebrahim A, Sauvageau E, Kallmes DF, Fiehler J, Hanel RA. Braids and beyond: a comprehensive study on pipeline device braid stability from PREMIER data. J Neurointerv Surg. 2025 Nov 18;17(12):1362-1367. doi: 10.1136/jnis-2024-022350.'}, {'pmid': '35292570', 'type': 'DERIVED', 'citation': 'Hanel RA, Cortez GM, Lopes DK, Nelson PK, Siddiqui AH, Jabbour P, Mendes Pereira V, Istvan IS, Zaidat OO, Bettegowda C, Colby GP, Mokin M, Schirmer CM, Hellinger FR, Given C, Krings T, Taussky P, Toth G, Fraser JF, Chen M, Priest R, Kan P, Fiorella D, Frei D, Aagaard-Kienitz B, Diaz O, Malek AM, Cawley CM, Puri AS, Kallmes DF. Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification. J Neurointerv Surg. 2023 Mar;15(3):248-254. doi: 10.1136/neurintsurg-2021-018501. Epub 2022 Mar 15.'}, {'pmid': '31308197', 'type': 'DERIVED', 'citation': 'Hanel RA, Kallmes DF, Lopes DK, Nelson PK, Siddiqui A, Jabbour P, Pereira VM, Szikora Istvan I, Zaidat OO, Bettegowda C, Colby GP, Mokin M, Schirmer C, Hellinger FR, Given Ii C, Krings T, Taussky P, Toth G, Fraser JF, Chen M, Priest R, Kan P, Fiorella D, Frei D, Aagaard-Kienitz B, Diaz O, Malek AM, Cawley CM, Puri AS. Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results. J Neurointerv Surg. 2020 Jan;12(1):62-66. doi: 10.1136/neurintsurg-2019-015091. Epub 2019 Jul 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and effectiveness of the Pipeline™ device in the treatment of unruptured, wide-neck intracranial aneurysms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject has provided written informed consent using the IRB/EC-approved consent form and agrees to comply with protocol requirements.\n2. Age 22-80 years.\n3. Subject has a target intracranial aneurysm (IA) located in the:\n\n 1. Internal carotid artery (up to the carotid terminus) OR\n 2. Vertebral artery segment up to and including the posterior inferior cerebellar artery\n4. Subject has a target IA that is ≤ 12 mm.\n5. Subject has a target IA that has a parent vessel with diameter 1.5-5.0 mm distal/proximal to the target IA.\n6. Subject has a target IA with an aneurysm neck ≥ 4mm or a dome to neck ratio ≤ 1.5.\n7. Subject has a pre-procedure PRU value between 60-200.\n\nExclusion Criteria:\n\n1. Subject has received an intracranial implant (e.g. coils) in the area of the target IA within the past 12 weeks.\n2. Subarachnoid hemorrhage in the past 30 days.\n3. Subject with anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis determined from baseline or pre-procedure imaging, or a history of intracranial vasospasm not responsive to medical therapy.\n4. Major surgery in the last 30 days.\n5. History of irreversible bleeding disorder and/or subject presents with signs of active bleeding.\n6. Any known contraindication to treatment with the Pipeline™ device, including:\n\n 1. Stent is in place in the parent artery at the target IA location\n 2. Contraindication to dual antiplatelet therapy\n 3. Relative contraindication to angiography (e.g., serum creatinine \\>2.5 mg/dL, allergy to contrast that cannot be medically controlled).\n 4. Known severe allergy to platinum or cobalt/chromium alloys.\n 5. Evidence of active infection at the time of treatment (e.g., fever with temperature \\>38°C and/or WBC \\>1.5 109/L).\n7. The Investigator determines that the health of the subject or the validity of the study outcomes (e.g., high risk of neurologic events, worsening of clinical condition in the last 30 days) may be compromised by the subject's enrollment.\n8. Pregnant or breast-feeding women or women who wish to become pregnant during the length of study participation.\n9. Participating in another clinical trial during the follow-up period that could confound the treatment or outcomes of this investigation."}, 'identificationModule': {'nctId': 'NCT02186561', 'acronym': 'PREMIER', 'briefTitle': 'Prospective Study on Embolization of Intracranial Aneurysms With Pipeline™ Embolization Device', 'nctIdAliases': ['NCT02178007'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Neurovascular Clinical Affairs'}, 'officialTitle': 'Prospective Study on Embolization of Intracranial Aneurysms With the Pipeline™ Device (PREMIER)', 'orgStudyIdInfo': {'id': 'NV-PED-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pipeline™ Embolization Device', 'description': 'treatment with Pipeline™ Embolization Device', 'interventionNames': ['Device: Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device']}], 'interventions': [{'name': 'Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device', 'type': 'DEVICE', 'armGroupLabels': ['Pipeline™ Embolization Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80112', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Radiology Imaging Associates', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Medical Center Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '32789', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'The Emory Clinic', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Baptist Physicians Lexington', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts University Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Memorial Medical Center', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Kaleida Health/University of Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook University', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '17822', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Medical Center', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "St. Luke's Health Baylor College of Medicine", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Hospital and Clinics', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Western Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Ricardo Hanel, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baptist Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No, there is not a plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Neurovascular Clinical Affairs', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}