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The purpose of this study is to assess the safety and effectiveness of the Pipelineâ„¢ device in the treatment of unruptured, wide-neck intracranial aneurysms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pipelineâ„¢ Embolization Device | Experimental | treatment with Pipelineâ„¢ Embolization Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pipelineâ„¢ Embolization Device/ Pipelineâ„¢Flex Embolization Device | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| The 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 | 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. | Up to 12 Months Post Procedure |
| 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 | 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. Multiple imputation provides a mechanism for deriving estimates for a population where not all of the patients have an endpoint determination. | Up to 12 Months Post Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
Not provided
Inclusion Criteria:
Subject has provided written informed consent using the IRB/EC-approved consent form and agrees to comply with protocol requirements.
Age 22-80 years.
Subject has a target intracranial aneurysm (IA) located in the:
Subject has a target IA that is ≤ 12 mm.
Subject has a target IA that has a parent vessel with diameter 1.5-5.0 mm distal/proximal to the target IA.
Subject has a target IA with an aneurysm neck ≥ 4mm or a dome to neck ratio ≤ 1.5.
Subject has a pre-procedure PRU value between 60-200.
Exclusion Criteria:
Subject has received an intracranial implant (e.g. coils) in the area of the target IA within the past 12 weeks.
Subarachnoid hemorrhage in the past 30 days.
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.
Major surgery in the last 30 days.
History of irreversible bleeding disorder and/or subject presents with signs of active bleeding.
Any known contraindication to treatment with the Pipelineâ„¢ device, including:
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.
Pregnant or breast-feeding women or women who wish to become pregnant during the length of study participation.
Participating in another clinical trial during the follow-up period that could confound the treatment or outcomes of this investigation.
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| Name | Affiliation | Role |
|---|---|---|
| Ricardo Hanel, M.D. | Baptist Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiology Imaging Associates | Englewood | Colorado | 80112 | United States | ||
| Baptist Medical Center Jacksonville |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39357888 | Derived | 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. | |
| 35292570 | Derived |
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No, there is not a plan to make IPD available.
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| ID | Title | Description |
|---|---|---|
| FG000 | PREMIER | The investigational device was implanted in the internal carotid artery (up to the terminus) or the vertebral artery segment up to and including the posterior inferior cerebellar artery to treat unruptured, wide-necked, aneurysms measuring ≤ 12 mm. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Enrollment |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 24, 2015 |
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| Up to 30 days, Post Procedure |
| The Number of Participants Who Experienced Delayed Intracerebral Hemorrhage > 30 Days Post-Procedure | 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. | > 30 days, Post Procedure |
| The Number of Participants With Successfully Deployed Investigational Device | The secondary outcome measures provides the number of participants successfully implanted with the Investigational device during the study index procedure at the target site. | Index Procedure |
| Jacksonville |
| Florida |
| 32207 |
| United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Florida Hospital | Winter Park | Florida | 32789 | United States |
| The Emory Clinic | Atlanta | Georgia | 30322 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Baptist Physicians Lexington | Lexington | Kentucky | 40503 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Tufts University Medical Center | Boston | Massachusetts | 02111 | United States |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Kaleida Health/University of Buffalo | Buffalo | New York | 14203 | United States |
| Stony Brook University | Stony Brook | New York | 11794 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| St. Luke's Health Baylor College of Medicine | Houston | Texas | 77030 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
| Toronto Western Hospital | Toronto | Ontario | M5T 2S8 | Canada |
| 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. |
| 31308197 | Derived | 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. |
|
| COMPLETED | Enrolled Participants in Whom Deployment of the Investigational Device was Attempted- ITT Population |
|
| NOT COMPLETED |
|
|
| Subjects Implanted With Device |
|
| 30-Day Post Index Procedure Visit |
|
|
| 180- Day Post Index Procedure Visit |
|
| 1- Year Post Index Procedure Visit |
|
|
| 2 - Year Post Index Procedure Visit |
|
| 3 - Year Post Index Procedure Visit |
|
Intent to Treat Population was defined as all enrolled participants in whom deployment of the Investigational device was attempted.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PREMIER | The investigational device was implanted in the internal carotid artery (up to the terminus) or the vertebral artery segment up to and including the posterior inferior cerebellar artery to treat unruptured, wide-necked, aneurysms measuring ≤ 12 mm. |
| 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 |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | 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 | The 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 | 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. | Participants enrolled and implanted with the Investigational Device (ITT) | Posted | Number | percentage of participants | Up to 12 Months Post Procedure |
|
|
| ||||||||||||||||||||||||||
| Primary | 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 | 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. Multiple imputation provides a mechanism for deriving estimates for a population where not all of the patients have an endpoint determination. | Participants Treated with Investigational Device that Completed the 12 Month Visit Imaging | Posted | Number | Percentage of Participants | Up to 12 Months Post Procedure |
| ||||||||||||||||||||||||||||
| Secondary | 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 | 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. | Participants Treated with the Investigational Device that Completed the 30 Day Visit | Posted | Count of Participants | Participants | Up to 30 days, Post Procedure |
|
| |||||||||||||||||||||||||||
| Secondary | The Number of Participants Who Experienced Delayed Intracerebral Hemorrhage > 30 Days Post-Procedure | 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. | ParticipantsTreated with the Investigational Device that Completed the 30 Day Visit | Posted | Number | Participants | > 30 days, Post Procedure |
|
| |||||||||||||||||||||||||||
| Secondary | The Number of Participants With Successfully Deployed Investigational Device | The secondary outcome measures provides the number of participants successfully implanted with the Investigational device during the study index procedure at the target site. | Participants Enrolled who Underwent the Index Procedure | Posted | Count of Participants | Participants | Index Procedure |
|
|
Adverse Events were collected from the point of consent through year 3
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.
Adjudicable events met the following criteria:
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CEC Adjudicated Adverse Events Through 1-Year | Participants who received the Investigational Device followed through 1 Year | 1 | 141 | 39 | 141 | 107 | 141 |
| EG001 | CEC Adjudicated Adverse Events Through 2-Year | Participants who received the Investigational Device followed through 2 Year | 1 | 141 | 49 | 141 | 112 | 141 |
| EG002 | CEC Adjudicated Adverse Events Through 3-Year | Participants who received the Investigational Device followed through 3 Year | 2 | 141 | 60 | 141 | 112 | 141 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Peritoneal haemorrhage | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Thrombosis in Device | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Colonic abscess | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Wound Infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Patella Fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Procedural hypertension | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Vascular Graft Occlusion | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Carotid Artery Dissection | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cerebral Haemorrhage | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cerebral Infarction | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Myasthenia Gravis | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Ovarian cyst ruptured | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Stevens-Johnson Syndrome | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Aneurysm repair | Surgical and medical procedures | MedDRA (17.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypertensive Crisis | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vascular Occlusion | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Lymphatic Disorder | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Gastritis Erosive | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Bronchopulmonary Aspergillosis Allergic | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Loss of Consciousness | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Ovarian Cyst | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Coronary Arterial Stent Insertion | Surgical and medical procedures | MedDRA (17.0) | Systematic Assessment |
| |
| Intervertebral Disc Operation | Surgical and medical procedures | MedDRA (17.0) | Systematic Assessment |
| |
| Medical Device Removal | Surgical and medical procedures | MedDRA (17.0) | Systematic Assessment |
| |
| Malignant Hypertension | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vascular Occlusion | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhagic Diathesis | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Lymphoid tissue hyperplasia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Amaurosis Fugax | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Blepharospasm | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Conjunctival Haemorrhage | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vitreous detachment | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Catheter site haematoma | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Catheter site haemorrhage | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Local swelling | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Periorbital Haemorrhage | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Spinal Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Carpal Tunnel Syndrome | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cerebral vasoconstriction | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Intracranial Artery Dissection | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Ischaemic Stroke | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Muscle spasticity | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Radiculitis Lumbosacral | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Sensory Disturbance | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Subarachnoid Heamorrhage | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Visual field defect | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dysphemia | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Swelling Face | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Arterial stenosis | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vasospasm | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Catheter Site Injury | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Modified Rankin Score Decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Cognitive Disorder | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Monoplegia | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Project Manager, Clinical Project Management | Medtronic Neurovascular, Clinical Affairs | 949-680-1274 | darren.j.lacour@medtronic.com |
| Apr 1, 2019 |
| Prot_SAP_000.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 |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|