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| Name | Class |
|---|---|
| ev3 International | INDUSTRY |
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The objective of this study was to obtain prospective clinical data on the safety and efficacy of the Solitaireâ„¢ FR device for patients diagnosed with acute ischemic stroke.
The Study was a multi-center, single-arm, prospective, observational evaluation. The Solitaireâ„¢ FR Device has been certified for CE mark. This protocol evaluated the safety and efficacy of the Solitaireâ„¢ FR Device when used in routine practice and according to its Instructions for Use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solitaireâ„¢ FR device | Eligible subjects treated with the Solitaireâ„¢ FR device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solitaireâ„¢ FR device | Device | Mechanical Thrombectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Arterial Recanalization of the Occluded Target Vessel Measured by Thrombolysis in Cerebral Infarction (TICI) Score Equal or Superior to 2b Following the Use of the Study Device. | Thrombolysis in Cerebral Infarction (TICI) score Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion | Immediately post procedure |
| Incidence of Device-related and Procedure-related Serious Adverse Events (SAEs). | Device-related and procedure-related Serious Adverse Events (SAEs). A clinically significant procedure complication is defined as a decline in NIHSS of ≥4 or access vessel complication requiring surgery or blood transfusion. | 90 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Achieve Revascularization - Groin Stick to Initial Angiogram and Final Solitaireâ„¢ FR Angiogram | Time from groin stick to initial angiogram and final Solitaireâ„¢ FR angiogram with Thrombolysis in Cerebral Infarction (TICI) score 2b or 3 flow Thrombolysis in Cerebral Infarction (TICI) score Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion |
Not provided
Inclusion Criteria:
Subject or subject's legally authorized representative has signed and dated an Informed Consent Form
Age ≥ 18 and < 85
Clinical signs consistent with acute ischemic stroke
Thrombolysis in Cerebral Infarction (TICI) 0 or TICI 1 flow in the proximal anterior intracranial vasculature (M1 or M2 of Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA) intracranial, Internal Carotid Artery (ICA) terminal)
Presentation within 8 hours of stroke onset according to local stroke protocol
If stroke presentation within 4.5 hours, one of these conditions can be met:
Subject is willing to conduct follow-up visits.
National Institutes of Health Stroke Scale (NIHSS) ≥ 8 and ≤ 30
Modified Rankin Scale (mRS) ≤ 2 prior to stroke onset
Exclusion Criteria:
Females who are pregnant or lactating
Known serious sensitivity to radiographic contrast agents
Neurological signs that are rapidly improving prior to or at time of treatment
Current participation in another investigational drug or device study
Life expectancy of less than 90 days
National Institutes of Health Stroke Scale (NIHSS) > 30 or coma
Uncontrolled hypertension defined as systolic blood pressure > 185 or diastolic blood pressure > 110 that cannot be controlled except with continuous parenteral antihypertensive medication
Use of warfarin anticoagulation with International Normalised Ratio (INR) > 3.0
Platelet count < 30,000
Glucose < 400 mg/dL
Previous stroke within 30 days
Time of symptom onset unknown
Seizure at the onset of stroke
Myocardial infarction or infection (sepsis or endocarditis)
Arterial tortuosity that would prevent the device from reaching the target vessel
Known hypersensitivity to nickel-titanium
Imaging Exclusion Criteria:
Angiographic evidence of carotid dissection, complete cervical carotid occlusions, or vasculitis
Stenosis proximal to thrombus site that may preclude safe recovery of the device
Brain computed tomography (CT) with signs of hemorrhage, arteriovenous venous malformations, or aneurysm
Early ischemic changes greater than 1/3 of the middle cerebral artery (MCA) territory or according to brain computed tomography (CT) Alberta Stroke Program Early CT (ASPECT) score ≤ 6 or according to magnetic resonance diffusion weighted imaging (MR DWI) ASPECT score <5
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Subjects having clinical signs and imaging criteria consistent with acute ischemic stroke who presented within 8 hours of stroke symptoms onset with the study device were considered for inclusion in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Vitor Mendes Pereira, Dr | HUG Geneva | Principal Investigator |
| Jan Gralla, Dr | Inselspital University Hospital of Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inselspital University Hospital of Bern | Bern | 3010 | Switzerland | |||
| Hôpitaux Universitaires de Genève (HUG) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31239326 | Derived | Raychev R, Saver JL, Jahan R, Nogueira RG, Goyal M, Pereira VM, Gralla J, Levy EI, Yavagal DR, Cognard C, Liebeskind DS. The impact of general anesthesia, baseline ASPECTS, time to treatment, and IV tPA on intracranial hemorrhage after neurothrombectomy: pooled analysis of the SWIFT PRIME, SWIFT, and STAR trials. J Neurointerv Surg. 2020 Jan;12(1):2-6. doi: 10.1136/neurintsurg-2019-014898. Epub 2019 Jun 25. | |
| 28097310 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Solitaireâ„¢ FR Device | Eligible subjects treated with the Solitaireâ„¢ FR device. Solitaireâ„¢ FR device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Pre-stroke mRS scores are missing for 24 subjects as it was not recorded or determinable.
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| ID | Title | Description |
|---|---|---|
| BG000 | Solitaireâ„¢ FR Device | Eligible subjects treated with the Solitaireâ„¢ FR device. |
| 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 | Arterial Recanalization of the Occluded Target Vessel Measured by Thrombolysis in Cerebral Infarction (TICI) Score Equal or Superior to 2b Following the Use of the Study Device. | Thrombolysis in Cerebral Infarction (TICI) score Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion | Due to insufficient imaging, the Core Lab was able to evaluate data from 190 subjects. | Posted | Number | percentage of particpants | Immediately post procedure |
|
90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
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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 | Solitaireâ„¢ FR Device | Eligible subjects treated with the Solitaireâ„¢ FR device. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manish Gupta, Sr. Director of Medical Affairs | Medtronic | 949-837-3700 | manish.gupta@medtronic.com |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| During procedure |
| Time to Achieve Revascularization - After First Ipsilateral Angiogram to Final Solitaireâ„¢ FR Angiogram | Time after first ipsilateral angiogram to final Solitaireâ„¢ FR angiogram with Thrombolysis in Cerebral Infarction (TICI) score 2b or 3 flow Thrombolysis in Cerebral Infarction (TICI) score Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion | During Procedure |
| Good Neurological Condition | Good neurological outcome (GNO), as defined in the protocol, is a modified Rankin Scale (mRS) score of less than or equal to 2, or National Institutes of Health Stroke Scale (NIHSS) score 0-1, or NIHSS score improvement of 10 points or more from the pre-procedure evaluation | 90 Days |
| Rate of Morbidity | 90 Days |
| Rate of Mortality | 90 Days |
| Incidence of Symptomatic Intracranial Hemorrhage | Symptomatic intracranial hemorrhage, defined as any parenchymal hematoma 1 (PH1), parenchymal hematoma 2 (PH2), intraparenchymal hemorrhage remote from the ischemic field (RIH), intraventricular hemorrhage (IVH), and subarachnoid hemorrhage (SAH) associated with a decline in National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24 hrs. PH1 - Hematoma within ischemic field with some mild space occupying effect but involving ≤ 30% PH2 - Hematoma within ischemic field with space-occupying effect involving > 30% of the infarcted area RIH - Any intraparenchymal hemorrhage remote from the ischemic field IVH - Intraventricular hemorrhage SAH - Subarachnoid hemorrhage | 24 hours |
| Immediate Flow Reperfusion | Immediate reperfusion observed when the Solitaireâ„¢ FR device is deployed within the thrombus - Thrombolysis in Cerebral Infarction (TICI) score 2b or 3. Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion | procedure |
| Geneva |
| 1211 |
| Switzerland |
| Derived |
| Coutinho JM, Liebeskind DS, Slater LA, Nogueira RG, Clark W, Davalos A, Bonafe A, Jahan R, Fischer U, Gralla J, Saver JL, Pereira VM. Combined Intravenous Thrombolysis and Thrombectomy vs Thrombectomy Alone for Acute Ischemic Stroke: A Pooled Analysis of the SWIFT and STAR Studies. JAMA Neurol. 2017 Mar 1;74(3):268-274. doi: 10.1001/jamaneurol.2016.5374. |
| 24876244 | Derived | Menon BK, Almekhlafi MA, Pereira VM, Gralla J, Bonafe A, Davalos A, Chapot R, Goyal M; STAR Study Investigators. Optimal workflow and process-based performance measures for endovascular therapy in acute ischemic stroke: analysis of the Solitaire FR thrombectomy for acute revascularization study. Stroke. 2014 Jul;45(7):2024-9. doi: 10.1161/STROKEAHA.114.005050. Epub 2014 May 15. |
| 24557701 | Derived | Almekhlafi MA, Davalos A, Bonafe A, Chapot R, Gralla J, Pereira VM, Goyal M; STAR Registry Investigators. Impact of age and baseline NIHSS scores on clinical outcomes in the mechanical thrombectomy using solitaire FR in acute ischemic stroke study. AJNR Am J Neuroradiol. 2014 Jul;35(7):1337-40. doi: 10.3174/ajnr.A3855. Epub 2014 Feb 20. |
| 23908066 | Derived | Pereira VM, Gralla J, Davalos A, Bonafe A, Castano C, Chapot R, Liebeskind DS, Nogueira RG, Arnold M, Sztajzel R, Liebig T, Goyal M, Besselmann M, Moreno A, Moreno A, Schroth G; the STAR Investigators. Prospective, multicenter, single-arm study of mechanical thrombectomy using Solitaire Flow Restoration in acute ischemic stroke. Stroke. 2013 Oct;44(10):2802-7. doi: 10.1161/STROKEAHA.113.001232. Epub 2013 Aug 1. |
| years |
|
| Gender | Count of Participants | Participants |
|
| Modified Rankin Scale (mRS) | The mRS measures degree of disability. (0 No symptoms at all, 1 No significant disability despite symptoms; able to carry out all usual duties and activities, 2 Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, 3 Moderate disability; requiring some help, but able to walk without assistance, 4 Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, 5 Severe disability; bedridden, incontinent and requiring constant nursing care and attention, 6 Dead) | Median | Inter-Quartile Range | Scores on a scale |
|
|
|
| Secondary | Time to Achieve Revascularization - Groin Stick to Initial Angiogram and Final Solitaireâ„¢ FR Angiogram | Time from groin stick to initial angiogram and final Solitaireâ„¢ FR angiogram with Thrombolysis in Cerebral Infarction (TICI) score 2b or 3 flow Thrombolysis in Cerebral Infarction (TICI) score Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion | Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size. | Posted | Mean | Standard Deviation | Minutes | During procedure |
|
|
|
| Secondary | Time to Achieve Revascularization - After First Ipsilateral Angiogram to Final Solitaireâ„¢ FR Angiogram | Time after first ipsilateral angiogram to final Solitaireâ„¢ FR angiogram with Thrombolysis in Cerebral Infarction (TICI) score 2b or 3 flow Thrombolysis in Cerebral Infarction (TICI) score Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion | Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size. | Posted | Mean | Standard Deviation | Minutes | During Procedure |
|
|
|
| Secondary | Good Neurological Condition | Good neurological outcome (GNO), as defined in the protocol, is a modified Rankin Scale (mRS) score of less than or equal to 2, or National Institutes of Health Stroke Scale (NIHSS) score 0-1, or NIHSS score improvement of 10 points or more from the pre-procedure evaluation | Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size. | Posted | Number | percentage of particpants | 90 Days |
|
|
|
| Secondary | Rate of Morbidity | Posted | Number | percentage of particpants | 90 Days |
|
|
|
| Secondary | Rate of Mortality | Posted | Number | percentage of particpants | 90 Days |
|
|
|
| Secondary | Incidence of Symptomatic Intracranial Hemorrhage | Symptomatic intracranial hemorrhage, defined as any parenchymal hematoma 1 (PH1), parenchymal hematoma 2 (PH2), intraparenchymal hemorrhage remote from the ischemic field (RIH), intraventricular hemorrhage (IVH), and subarachnoid hemorrhage (SAH) associated with a decline in National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24 hrs. PH1 - Hematoma within ischemic field with some mild space occupying effect but involving ≤ 30% PH2 - Hematoma within ischemic field with space-occupying effect involving > 30% of the infarcted area RIH - Any intraparenchymal hemorrhage remote from the ischemic field IVH - Intraventricular hemorrhage SAH - Subarachnoid hemorrhage | Posted | Number | percentage of particpants | 24 hours |
|
|
|
| Secondary | Immediate Flow Reperfusion | Immediate reperfusion observed when the Solitaireâ„¢ FR device is deployed within the thrombus - Thrombolysis in Cerebral Infarction (TICI) score 2b or 3. Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion | Due to insufficient imaging, the Core Lab was able to evaluated data from 190 subjects. | Posted | Number | percentage of participants | procedure |
|
|
|
| Primary | Incidence of Device-related and Procedure-related Serious Adverse Events (SAEs). | Device-related and procedure-related Serious Adverse Events (SAEs). A clinically significant procedure complication is defined as a decline in NIHSS of ≥4 or access vessel complication requiring surgery or blood transfusion. | Posted | Number | percentage of events | 90 Days |
|
|
|
| 59 |
| 202 |
| 143 |
| 202 |
| Atrioventricular block complete | Cardiac disorders | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | Systematic Assessment |
|
| Congestive cardiomyopathy | Cardiac disorders | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | Systematic Assessment |
|
| Gallstone ileus | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Catheter site haematoma | General disorders | Systematic Assessment |
|
| Death | General disorders | Systematic Assessment |
|
| Thrombosis in device | General disorders | Systematic Assessment |
|
| Bronchitis | Infections and infestations | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Pseudomembranous colitis | Infections and infestations | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Endotracheal intubation complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Electrocardiogram ST segment depression | Investigations | Systematic Assessment |
|
| Heart rate irregular | Investigations | Systematic Assessment |
|
| International normalised ratio increased | Investigations | Systematic Assessment |
|
| Pseudomonas test positive | Investigations | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Rectal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Thyroid cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | Systematic Assessment |
|
| Cerebral artery occlusion | Nervous system disorders | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
|
| Coma | Nervous system disorders | Systematic Assessment |
|
| Convulsion | Nervous system disorders | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | Systematic Assessment |
|
| Haemorrhagic stroke | Nervous system disorders | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | Systematic Assessment |
|
| Hemiplegia | Nervous system disorders | Systematic Assessment |
|
| Intracranial artery dissection | Nervous system disorders | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | Systematic Assessment |
|
| Neurological decompensation | Nervous system disorders | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | Systematic Assessment |
|
| Syncope | Nervous system disorders | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | Systematic Assessment |
|
| Delirium tremens | Psychiatric disorders | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cardiac pacemaker replacement | Surgical and medical procedures | Systematic Assessment |
|
| Cranioplasty | Surgical and medical procedures | Systematic Assessment |
|
| Gastrostomy tube insertion | Surgical and medical procedures | Systematic Assessment |
|
| Heart valve replacement | Surgical and medical procedures | Systematic Assessment |
|
| Tracheostomy | Surgical and medical procedures | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
|
| Embolism | Vascular disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Vascular dissection | Vascular disorders | Systematic Assessment |
|
| Vessel perforation | Vascular disorders | Systematic Assessment |
|
| Aspiration bronchial | Investigations | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | Systematic Assessment |
|
| Left ventricular failure | Cardiac disorders | Systematic Assessment |
|
| Mitral valve stenosis | Cardiac disorders | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | Systematic Assessment |
|
| Diplopia | Eye disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Oesophageal rupture | Gastrointestinal disorders | Systematic Assessment |
|
| Tongue haematoma | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Device leakage | General disorders | Systematic Assessment |
|
| Adverse drug reaction | General disorders | Systematic Assessment |
|
| Application site eczema | General disorders | Systematic Assessment |
|
| Device difficult to use | General disorders | Systematic Assessment |
|
| Unevaluable event | General disorders | Systematic Assessment |
|
| Hepatocellular injury | Hepatobiliary disorders | Systematic Assessment |
|
| Bacterial prostatitis | Infections and infestations | Systematic Assessment |
|
| Bacterial pyelonephritis | Infections and infestations | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Lung infection | Infections and infestations | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | Systematic Assessment |
|
| Oral fungal infection | Infections and infestations | Systematic Assessment |
|
| Parotitis | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Secondary syphilis | Infections and infestations | Systematic Assessment |
|
| Skin infection | Infections and infestations | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection enterococcal | Infections and infestations | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Eye injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Postoperative ileus | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Procedural site reaction | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Aspiration bronchial | Investigations | Systematic Assessment |
|
| Brain natriuretic peptide increased | Investigations | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | Systematic Assessment |
|
| Thyroid function test abnormal | Investigations | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | Systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypovitaminosis | Metabolism and nutrition disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| CREST syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | Systematic Assessment |
|
| Basilar artery stenosis | Nervous system disorders | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | Systematic Assessment |
|
| Cerebral artery embolism | Nervous system disorders | Systematic Assessment |
|
| Cerebral artery occlusion | Nervous system disorders | Systematic Assessment |
|
| Cerebral artery stenosis | Nervous system disorders | Systematic Assessment |
|
| Cerebral haematoma | Nervous system disorders | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | Systematic Assessment |
|
| Cerebral thrombosis | Nervous system disorders | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
|
| Cerebrovascular spasm | Nervous system disorders | Systematic Assessment |
|
| Convulsion | Nervous system disorders | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | Systematic Assessment |
|
| Haemorrhagic transformation stroke | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Intracranial artery dissection | Nervous system disorders | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | Systematic Assessment |
|
| IVth nerve paresis | Nervous system disorders | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | Systematic Assessment |
|
| Syncope | Nervous system disorders | Systematic Assessment |
|
| Tonic convulsion | Nervous system disorders | Systematic Assessment |
|
| Vascular headache | Nervous system disorders | Systematic Assessment |
|
| Vertebral artery occlusion | Nervous system disorders | Systematic Assessment |
|
| Agitation | Psychiatric disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Apathy | Psychiatric disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | Systematic Assessment |
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| Post stroke depression | Psychiatric disorders | Systematic Assessment |
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| Leukocyturia | Renal and urinary disorders | Systematic Assessment |
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| Lung disorder | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Respiratory fremitus | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pruritus generalised | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Purpura | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Air embolism | Vascular disorders | Systematic Assessment |
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| Aortic arteriosclerosis | Vascular disorders | Systematic Assessment |
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| Embolism | Vascular disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Hypertensive crisis | Vascular disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Vascular dissection | Vascular disorders | Systematic Assessment |
|
| Vasospasm | Vascular disorders | Systematic Assessment |
|
Physician shall not make any publication without providing Sponsor 60 days notice.If Sponsor determines that the proposed publication contains confidential information, Sponsor may require the delay of publication for a period of time not to exceed 90 days and may require that any confidential information be removed from the publication. Sponsor may also require Physician to delay publication until any factual errors or inaccuracies in the publication are corrected.
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |