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Single arm study to evaluate the outcomes of treatment with the Barrel VRD device as an adjunctive treatment to coiling for wide neck, intracranial, bifurcating/branching aneurysms in the middle cerebral and basilar arteries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BARREL VRD | Experimental | The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BARREL VRD | Device | The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Neurologic Death or Major Ipsilateral Stroke Within 12 Month Follow-up Period. | The primary safety endpoint was the number of participants reported with a neurological death or major ipsilateral stroke (National Institute of Stroke Scale (NIHSS) increase of ≥ 4 for > 24 hours) at any time during the follow-up period. The NIHSS is a tool used to quantify neurological impairment caused by stroke. The scale interpretation is as follows: 0: No stroke symptoms 1-4: Minor stroke symptoms 5-15: Moderate stroke 16-20: Moderate to severe stroke 21-42: Severe strokeThe National Institutes of Health Stroke Scale | 12 months, after device implant |
| Number of Participants With Raymond Grade I ( 100%) Occlusion of the Aneurysms for Participants Treated With the Barrel VRD at 12 Months in the Absence of Retreatment, Parent Artery Stenosis, or Target Aneurysm Rupture | The primary effectiveness endpoint was the count of participants achieving Raymond Grade I (100% occlusion) of the aneurysm treated with the Barrel VRD at 12 months ± 8 weeks in the absence of retreatment, parent artery stenosis (>50%), or target aneurysm rupture The Raymond Grade Classification definitions evaluated by an independent core laboratory are as follows: Class 1: Complete occlusion - complete obliteration of the aneurysm. Class 2: Residual neck - persistence of any portion of the original defect of the arterial wall as seen on any single projection, but without opacification of the aneurysmal sac. Class 3: Residual aneurysm - opacification of the aneurysmal sac | 12 months, after device implant |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Successfully Deployed Barrel VRD | This secondary outcome measure provides the number of subjects successfully implanted with the Barrel VRD. | Index Procedure, Day 0 |
| Number of Participants With Raymond Grade I (100% Complete Occlusion) and Raymond Grade II (Residual Neck) for Participants Treated With the Barrel VRD, in the Absence of Retreatment, Parent Artery Stenosis (>50%), or Target Aneurysm Rupture at 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Reported Device Related Serious Adverse Events | This secondary outcome measure provides the count of participants reported with a Serious Device Related Adverse Events | From the point of consent until participant exits the study at 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J Mocco, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Medical Center Jacksonville | Jacksonville | Florida | 32207 | United States | ||
| Baptist Hospital of Miami, BCVI |
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| ID | Title | Description |
|---|---|---|
| FG000 | BARREL VRD | The Barrel VRD was implanted as an adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries. BARREL VRD: The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment |
|
| ||||||||||||||||||
| Index Procedure With Barrel VRD Attempt |
| |||||||||||||||||||
| Follow-Up Post Barrel VRD Implanted |
|
Participants with enrolled (consented ) with an attempted Barrel VRD Implant
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| ID | Title | Description |
|---|---|---|
| BG000 | BARREL VRD | The Barrel VRD was implanted as an adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries. BARREL VRD: The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Neurologic Death or Major Ipsilateral Stroke Within 12 Month Follow-up Period. | The primary safety endpoint was the number of participants reported with a neurological death or major ipsilateral stroke (National Institute of Stroke Scale (NIHSS) increase of ≥ 4 for > 24 hours) at any time during the follow-up period. The NIHSS is a tool used to quantify neurological impairment caused by stroke. The scale interpretation is as follows: 0: No stroke symptoms 1-4: Minor stroke symptoms 5-15: Moderate stroke 16-20: Moderate to severe stroke 21-42: Severe strokeThe National Institutes of Health Stroke Scale | Participants implanted with the Barrel VRD | Posted | Count of Participants | Participants | 12 months, after device implant |
|
Adverse Events were collected from the point of consent through the study exit at 12 months.
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:
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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 | BARREL VRD | The Barrel VRD was implanted as an adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries. BARREL VRD: The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter site haemorrhage | General disorders | MedDRA (17.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager, Clinical Project Management | Medtronic Plc | 949-680-1274 | darren.j.lacour@medtronic.com |
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| 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 | May 18, 2016 | Aug 28, 2018 | Prot_SAP_000.pdf |
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This secondary outcome measure provides the count of participants treated with the Barrel VRD with Independent Core Laboratory aneurysm occlusion imaging evaluations of Complete Occlusion (Raymond Grade I) and Residual Aneurysm Neck (Raymond Grade II) at 12 months combined. Subjects with evidence of parent artery stenosis, retreatment, or rupture were not considered success. Raymond Grade Scale Class 1: Complete occlusion - complete obliteration of the aneurysm. Class 2: Residual neck - persistence of any portion of the original defect of the arterial wall as seen on any single projection, but without opacification of the aneurysmal sac. Class 3: Residual aneurysm - opacification of the aneurysmal sac. |
| 12 months, after device implant |
| Number of Participants With Modified Rankin Score of 0-2 or no Change From Baseline | This secondary outcome provides the count of participants treated with the Barrel device with a Modified Rankin Score of 0-2 at 12 months or no change from baseline. The Modified Rankin Score is a scale for measuring general functionality as follows: 0: No symptoms at all
| 12 months, after device implant |
| Number of Participants With Angiographic Evidence of In-stent Stenosis at 12 Months +/- 8 Weeks Reported According to the Following Ordinal Groups: <25%, 25-50%, 51-75%, >75% | This secondary measure provides the count of participants with parent artery stenosis per an independent core lab evaluation within the following ordinal groups: <25%, 25-50%, 51-75%, >75%. | At 12 Months +/- 8 weeks |
| Number of Participants With Any Cause of Death Within 30 Days or Neurological Death Within 12 Months +/- 8 Weeks | This secondary outcome measure provides the combined number and percentage of subjects that died within 30 days or had a neurologic death within 12 months of receiving the study device. | 30 Days and 12 months +/- 8 weeks |
| Miami |
| Florida |
| 33176 |
| United States |
| Tallahassee Neurological Clinic | Tallahassee | Florida | 32308 | United States |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Number of Participants With Raymond Grade I ( 100%) Occlusion of the Aneurysms for Participants Treated With the Barrel VRD at 12 Months in the Absence of Retreatment, Parent Artery Stenosis, or Target Aneurysm Rupture | The primary effectiveness endpoint was the count of participants achieving Raymond Grade I (100% occlusion) of the aneurysm treated with the Barrel VRD at 12 months ± 8 weeks in the absence of retreatment, parent artery stenosis (>50%), or target aneurysm rupture The Raymond Grade Classification definitions evaluated by an independent core laboratory are as follows: Class 1: Complete occlusion - complete obliteration of the aneurysm. Class 2: Residual neck - persistence of any portion of the original defect of the arterial wall as seen on any single projection, but without opacification of the aneurysmal sac. Class 3: Residual aneurysm - opacification of the aneurysmal sac | Subjects treated with the Barrel VRD that completed the 12 month visit imaging | Posted | Count of Participants | Participants | 12 months, after device implant |
|
|
|
| Secondary | Number of Participants With Successfully Deployed Barrel VRD | This secondary outcome measure provides the number of subjects successfully implanted with the Barrel VRD. | Posted | Count of Participants | Participants | Index Procedure, Day 0 |
|
|
|
| Secondary | Number of Participants With Raymond Grade I (100% Complete Occlusion) and Raymond Grade II (Residual Neck) for Participants Treated With the Barrel VRD, in the Absence of Retreatment, Parent Artery Stenosis (>50%), or Target Aneurysm Rupture at 12 Months | This secondary outcome measure provides the count of participants treated with the Barrel VRD with Independent Core Laboratory aneurysm occlusion imaging evaluations of Complete Occlusion (Raymond Grade I) and Residual Aneurysm Neck (Raymond Grade II) at 12 months combined. Subjects with evidence of parent artery stenosis, retreatment, or rupture were not considered success. Raymond Grade Scale Class 1: Complete occlusion - complete obliteration of the aneurysm. Class 2: Residual neck - persistence of any portion of the original defect of the arterial wall as seen on any single projection, but without opacification of the aneurysmal sac. Class 3: Residual aneurysm - opacification of the aneurysmal sac. | Outcomes are based on observed data (i.e., 106 participants with 12-month evaluable imaging). 21/127 participants did not have evaluable imaging at 1-Year. | Posted | Count of Participants | Participants | 12 months, after device implant |
|
|
|
| Secondary | Number of Participants With Modified Rankin Score of 0-2 or no Change From Baseline | This secondary outcome provides the count of participants treated with the Barrel device with a Modified Rankin Score of 0-2 at 12 months or no change from baseline. The Modified Rankin Score is a scale for measuring general functionality as follows: 0: No symptoms at all
| Outcomes are based on observed data, from 111 participants completed at 1-year and 3 participants with an mRS score of 6 (death) prior to 1 year. | Posted | Count of Participants | Participants | 12 months, after device implant |
|
|
|
| Secondary | Number of Participants With Angiographic Evidence of In-stent Stenosis at 12 Months +/- 8 Weeks Reported According to the Following Ordinal Groups: <25%, 25-50%, 51-75%, >75% | This secondary measure provides the count of participants with parent artery stenosis per an independent core lab evaluation within the following ordinal groups: <25%, 25-50%, 51-75%, >75%. | Outcomes are based on observed data on 89 participants with evaluable angiographic data at 1 year. 38/127 participants did not have angiographic data at 1 year available for analysis. | Posted | Count of Participants | Participants | At 12 Months +/- 8 weeks |
|
|
|
| Secondary | Number of Participants With Any Cause of Death Within 30 Days or Neurological Death Within 12 Months +/- 8 Weeks | This secondary outcome measure provides the combined number and percentage of subjects that died within 30 days or had a neurologic death within 12 months of receiving the study device. | Posted | Count of Participants | Participants | 30 Days and 12 months +/- 8 weeks |
|
|
|
| Other Pre-specified | Number of Participants With Reported Device Related Serious Adverse Events | This secondary outcome measure provides the count of participants reported with a Serious Device Related Adverse Events | Subjects with an Attempted Barrel VRD Implant | Posted | Count of Participants | Participants | From the point of consent until participant exits the study at 1 year |
|
|
|
| 3 |
| 127 |
| 44 |
| 127 |
| 73 |
| 127 |
| Acute myocardial infarction | Cardiac disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Cardiopulmonary failure | Cardiac disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Catheter site haematoma | General disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
|
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Glioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Non-systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Non-systematic Assessment |
|
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Non-systematic Assessment |
|
| Retroperitoneal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Non-systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Status epilepticus | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Vertebral artery dissection | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Glomerulonephritis rapidly progressive | Renal and urinary disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Spinal decompression | Surgical and medical procedures | MedDRA (17.1) | Non-systematic Assessment |
|
| Aneurysm | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Hypertensive emergency | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Eyelid ptosis | Eye disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Photopsia | Eye disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Oral mucosal blistering | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Catheter site haematoma | General disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Catheter site inflammation | General disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Catheter site swelling | General disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Drug intolerance | General disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Local swelling | General disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Thrombosis in device | General disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
|
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
|
| Procedural hypertension | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
|
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
|
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
|
| Wound secretion | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Cerebral artery thrombosis | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Spondylitic myelopathy | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Urethral pain | Renal and urinary disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Aneurysm repair | Surgical and medical procedures | MedDRA (17.1) | Non-systematic Assessment |
|
| Aneurysm | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Arterial stenosis | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Intermittent claudication | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Vasospasm | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
|
Not provided
Not provided
| In-Stent Stenosis at 12 Months < 75% |
|