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| Name | Class |
|---|---|
| Medtronic Cardiac Rhythm and Heart Failure | INDUSTRY |
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This is a prospective, single-arm, multi-center post-market observational study assessing the performance of the Pipelineâ„¢ Flex Embolization Device with Shield Technologyâ„¢ in subjects undergoing treatment for intracranial aneurysms in a large real-world, post-market setting.
Eligible subjects will be treated with the Pipelineâ„¢ Flex Embolization Device with Shield Technologyâ„¢.
Subjects will undergo standard of care follow-up visits. Data generated per standard of care will be collected for 1 year beyond the index procedure.
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402 (j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402 (j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pipelineâ„¢ Flex Embolization Device with Shield Technologyâ„¢ | Device | Pipelineâ„¢ Flex Embolization Device with Shield Technologyâ„¢ utilizes a phosphorylcholine (PC) surface treatment to the implant combined with the PFED delivery system. The Shield Technologyâ„¢ surface treatment applied to the implant is an inert polymer material created to mimic the outer membrane of a human red blood cell. The Pipelineâ„¢ Flex Embolization Device with Shield Technologyâ„¢ is intended for endovascular embolization of cerebral aneurysms and is designed to be placed across the opening (or 'neck') of a brain aneurysm and redirect blood flow away from the aneurysm, causing the blood within the aneurysm to clot. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Stroke/Death Occurrence | Percentage (%) of Participants who experienced a major stroke in the territory supplied by the treated artery or neurological death post-procedure (1-year) | 1 year |
| Effectiveness - Aneurysm Occlusion | Percentage (%) of Participants who have achieved complete aneurysm occlusion (defined as Raymond-Roy grade 1) without significant parent artery stenosis (≤ 50%) or retreatment of the target aneurysm post-procedure (1-year) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Stroke/Death Occurrence - 30 Days | Percentage (%) of Participants who experienced a major stroke in the territory supplied by the treated artery or neurological death at 30 days post-procedure due to procedural complications | 30 days |
| Safety - Intracerebral Hemorrhage (ICH) |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who have an intracranial aneurysm (IA). The Pipelineâ„¢ Flex Embolization Device with Shield Technologyâ„¢ will be used according to its Instructions for Use and its intended use during the treatment regimen.
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| Name | Affiliation | Role |
|---|---|---|
| Saleh Lamin | The Queen Elizabeth Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gold Coast University Hospital | Southport | QLD 4215 | Australia | |||
| Rigshospitalet |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21148256 | Background | Nelson PK, Lylyk P, Szikora I, Wetzel SG, Wanke I, Fiorella D. The pipeline embolization device for the intracranial treatment of aneurysms trial. AJNR Am J Neuroradiol. 2011 Jan;32(1):34-40. doi: 10.3174/ajnr.A2421. Epub 2010 Dec 9. | |
| 23418004 | Background | Becske T, Kallmes DF, Saatci I, McDougall CG, Szikora I, Lanzino G, Moran CJ, Woo HH, Lopes DK, Berez AL, Cher DJ, Siddiqui AH, Levy EI, Albuquerque FC, Fiorella DJ, Berentei Z, Marosfoi M, Cekirge SH, Nelson PK. Pipeline for uncoilable or failed aneurysms: results from a multicenter clinical trial. Radiology. 2013 Jun;267(3):858-68. doi: 10.1148/radiol.13120099. Epub 2013 Feb 15. |
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No individual participant data will be available
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Patients have been enrolled in 21 sites in EU, Australia and Israel between 24-Mar-2016 and 27-Sep-2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intention to Treat (ITT) | Includes all consented subjects in whom deployment of the Pipelineâ„¢ Shield device was attempted. For the ITT population, primary effectiveness endpoint analysis was based on Full Analysis Set (FAS) population and safety analysis was based on the ITT population. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 24, 2016 | Dec 21, 2021 |
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Percentage (%) of Participants who experienced a delayed intracerebral hemorrhage > 30 days post-procedure |
| 1 year |
| Effectiveness - Deployment Rate | Percentage (%) of Participants who have had a successful deployment of the device at the target site. A device is considered properly deployed when it covers the entire length of the aneurysm neck. | 1 year |
| Copenhagen |
| 2100 |
| Denmark |
| Turun Yliopistollinen keskussairaala | Turku | Finland |
| Hôpital Bicêtre | Le Kremlin-Bicêtre | France |
| Universitätsklinikum Augsburg | Augsburg | Germany |
| Charité Centrum | Berlin | Germany |
| Alfried Krupp Krankenhaus | Essen | Germany |
| Universitätsklinikums Heidelberg | Heidelberg | Germany |
| Universitätsklinikum des Saarlandes | Homburg | Germany |
| Hellenic Airforce Hospital | Athens | Greece |
| Országos Klinikai Idegtudományi Intézet | Budapest | Hungary |
| Hadassah Medical Organization | Jerusalem | Israel |
| Ospedale M. Bufalini | Cesena | Italy |
| Istituto Neurologico Carlo Besta | Milan | Italy |
| Hospital Universitario Cruces | Barakaldo | Spain |
| Hospital Fundación Jiménez DÃaz | Madrid | 28040 | Spain |
| Hospital Universitario de la Princesa | Madrid | Spain |
| Hospital Universitario Puerta de Hierro | Madrid | Spain |
| Hospital Universitario Central de Asturias | Oviedo | Spain |
| Queen Elizabeth Hospital | Birmingham | B15 2TH | United Kingdom |
| Royal Preston Hospital | Preston | United Kingdom |
| 25355814 | Background | Kallmes DF, Hanel R, Lopes D, Boccardi E, Bonafe A, Cekirge S, Fiorella D, Jabbour P, Levy E, McDougall C, Siddiqui A, Szikora I, Woo H, Albuquerque F, Bozorgchami H, Dashti SR, Delgado Almandoz JE, Kelly ME, Turner R 4th, Woodward BK, Brinjikji W, Lanzino G, Lylyk P. International retrospective study of the pipeline embolization device: a multicenter aneurysm treatment study. AJNR Am J Neuroradiol. 2015 Jan;36(1):108-15. doi: 10.3174/ajnr.A4111. Epub 2014 Oct 29. |
| 22653389 | Background | Chitale R, Gonzalez LF, Randazzo C, Dumont AS, Tjoumakaris S, Rosenwasser R, Chalouhi N, Gordon D, Jabbour P. Single center experience with pipeline stent: feasibility, technique, and complications. Neurosurgery. 2012 Sep;71(3):679-91; discussion 691. doi: 10.1227/NEU.0b013e318260fe86. |
| 22821921 | Background | Saatci I, Yavuz K, Ozer C, Geyik S, Cekirge HS. Treatment of intracranial aneurysms using the pipeline flow-diverter embolization device: a single-center experience with long-term follow-up results. AJNR Am J Neuroradiol. 2012 Sep;33(8):1436-46. doi: 10.3174/ajnr.A3246. Epub 2012 Jul 19. |
| 22948199 | Background | Kan P, Siddiqui AH, Veznedaroglu E, Liebman KM, Binning MJ, Dumont TM, Ogilvy CS, Gaughen JR Jr, Mocco J, Velat GJ, Ringer AJ, Welch BG, Horowitz MB, Snyder KV, Hopkins LN, Levy EI. Early postmarket results after treatment of intracranial aneurysms with the pipeline embolization device: a U.S. multicenter experience. Neurosurgery. 2012 Dec;71(6):1080-7; discussion 1087-8. doi: 10.1227/NEU.0b013e31827060d9. |
| 22996749 | Background | Yu SC, Kwok CK, Cheng PW, Chan KY, Lau SS, Lui WM, Leung KM, Lee R, Cheng HK, Cheung YL, Chan CM, Wong GK, Hui JW, Wong YC, Tan CB, Poon WL, Pang KY, Wong AK, Fung KH. Intracranial aneurysms: midterm outcome of pipeline embolization device--a prospective study in 143 patients with 178 aneurysms. Radiology. 2012 Dec;265(3):893-901. doi: 10.1148/radiol.12120422. Epub 2012 Sep 20. |
| 21979492 | Background | McAuliffe W, Wycoco V, Rice H, Phatouros C, Singh TJ, Wenderoth J. Immediate and midterm results following treatment of unruptured intracranial aneurysms with the pipeline embolization device. AJNR Am J Neuroradiol. 2012 Jan;33(1):164-70. doi: 10.3174/ajnr.A2727. Epub 2011 Oct 6. |
| 25385746 | Background | Skukalek SL, Winkler AM, Kang J, Dion JE, Cawley CM, Webb A, Dannenbaum MJ, Schuette AJ, Asbury B, Tong FC. Effect of antiplatelet therapy and platelet function testing on hemorrhagic and thrombotic complications in patients with cerebral aneurysms treated with the pipeline embolization device: a review and meta-analysis. J Neurointerv Surg. 2016 Jan;8(1):58-65. doi: 10.1136/neurintsurg-2014-011145. Epub 2014 Nov 10. |
| 32482834 | Derived | Rice H, Martinez Galdamez M, Holtmannspotter M, Spelle L, Lagios K, Ruggiero M, Vega P, Sonwalkar H, Chapot R, Lamin S. Periprocedural to 1-year safety and efficacy outcomes with the Pipeline Embolization Device with Shield technology for intracranial aneurysms: a prospective, post-market, multi-center study. J Neurointerv Surg. 2020 Nov;12(11):1107-1112. doi: 10.1136/neurintsurg-2020-015943. Epub 2020 Jun 1. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intention to Treat (ITT) | Includes all consented subjects in whom deployment of the Pipelineâ„¢ Shield device was attempted. For the ITT population, primary effectiveness endpoint analysis was based on Full Analysis Set (FAS) population and safety analysis was based on the ITT population. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety - Stroke/Death Occurrence | Percentage (%) of Participants who experienced a major stroke in the territory supplied by the treated artery or neurological death post-procedure (1-year) | Posted | Number | 95% Confidence Interval | percentage of patients with event | 1 year |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Effectiveness - Aneurysm Occlusion | Percentage (%) of Participants who have achieved complete aneurysm occlusion (defined as Raymond-Roy grade 1) without significant parent artery stenosis (≤ 50%) or retreatment of the target aneurysm post-procedure (1-year) | Primary effectiveness endpoint was analyzed specifically on subjects with successful device implantation (FAS population, N=200). | Posted | Number | 95% Confidence Interval | percentage of patients | 1 year |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Safety - Stroke/Death Occurrence - 30 Days | Percentage (%) of Participants who experienced a major stroke in the territory supplied by the treated artery or neurological death at 30 days post-procedure due to procedural complications | Posted | Count of Participants | Participants | 30 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Safety - Intracerebral Hemorrhage (ICH) | Percentage (%) of Participants who experienced a delayed intracerebral hemorrhage > 30 days post-procedure | Posted | Count of Participants | Participants | 1 year |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Effectiveness - Deployment Rate | Percentage (%) of Participants who have had a successful deployment of the device at the target site. A device is considered properly deployed when it covers the entire length of the aneurysm neck. | Posted | Count of Participants | Participants | 1 year |
|
|
Adverse Events have been collected through 1 year from study procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intention to Treat (ITT) | Includes all consented subjects in whom deployment of the Pipelineâ„¢ Shield device was attempted. For the ITT population, primary effectiveness endpoint analysis was based on Full Analysis Set (FAS) population and safety analysis was based on the ITT population. | 2 | 204 | 44 | 204 | 74 | 204 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal artery occlusion | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vascular procedure complication | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cerebral artery embolism | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cerebral microembolism | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Intracranial mass | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ischaemic cerebral infarction | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| VIth nerve paralysis | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Aneurysm repair | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haemorrhagic diathesis | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haematoma infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vascular access site pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cerebral artery occlusion | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cerebral vasoconstriction | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cranial nerve palsies multiple | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haemorrhagic transformation stroke | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ruptured cerebral aneurysm | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Laryngospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Embolism venous | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vasospasm | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhagic diathesis | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Increased tendency to bruise | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vascular stent stenosis | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Post procedural discomfort | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Post procedural haematuria | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Procedural headache | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vascular access site haematoma | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vascular access site haemorrhage | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vascular access site pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cerebral artery occlusion | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ischaemic cerebral infarction | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pharyngeal haematoma | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vascular wall hypertrophy | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Claudia Campo | Medtronic Neurovascular | 0039 0224137325 | claudia.campo@medtronic.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 12, 2019 | Dec 21, 2021 | SAP_003.pdf |
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Finland |
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| Denmark |
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| Italy |
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| United Kingdom |
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| Israel |
|
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| Australia |
|
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| France |
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| Germany |
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| Spain |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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