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The purpose of this study is to demonstrate substantial equivalence of the SOLITAIRE™ FR Revascularization Device (SOLITAIRE™ Device) with a legally marketed device, MERCI Retrieval System® (MERCI® Device). The study will demonstrate safety and efficacy of the SOLITAIRE™ Device in subjects requiring mechanical thrombectomy diagnosed with acute ischemic stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOLITAIREâ„¢ Device | Experimental | The SOLITAIREâ„¢ Device (investigational device) is the experimental arm |
|
| MERCI® Device | Active Comparator | The MERCI® Device (control device) is commercially available. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOLITAIREâ„¢ Device | Device | The SOLITAIREâ„¢ Device is the experimental device that will be used in the interventional procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recanalization [Thrombolysis in Myocardial Infarction (TIMI) 2 or 3] Without Symptomatic Intracranial Hemorrhage | Successful arterial recanalization of occluded target vessel measured by Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following the use of the SOLITAIRE™ or MERCI® Device without any symptomatic intracranial hemorrhage and rescue therapy within 3 passes. Thrombolysis in Myocardial Infarction (TIMI) score describes the distal flow perfusion and revascularization before and following therapy. TIMI 0 - No perfusion (worst outcome) TIMI 1 - Perfusion past the initial occlusion, but no distal branch filling TIMI 2 - Perfusion with incomplete or slow distal branch filling TIMI 3 - Full perfusion with filling of all distal branches (best outcome) | Immediately post treatment |
| Study Device-related Serious Adverse Events (SAEs) | Incidence of study device-related Serious Adverse Events (SAEs) | 90 Day |
| Procedure-related Serious Adverse Events (SAEs) | Incidence of study procedure-related Serious Adverse Events (SAEs) | 90 Day |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Initial Recanalization | Time from guide catheter placement to first visualization of Thrombolysis in Myocardial Infarction (TIMI) 2 flow | post treatment |
| Good Neurological Outcome at 30 Days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey L. Saver, MD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Stroke Center | Portland | Oregon | United States | |||
| Multicare Health System |
| 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 |
| Label | URL |
|---|---|
| American Heart Association - Stroke | View source |
Not provided
Study had Roll-in period. Participating centers in the United States were required to enroll two (2) roll-in subjects prior to the subject randomization. There were a total of 31 roll-in subjects. Only data from the randomized cohort was used for both primary efficacy analysis and the safety endpoint analysis.
Subject enrolled from Feb 2010 to Feb 2011. Subject randomized to Solitaire or Merci by baseline National Institutes of Health Stroke Scale Score.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SOLITAIREâ„¢ Device | The SOLITAIREâ„¢ Device (investigational device) is the experimental arm |
| FG001 | MERCI® Device | The MERCI® Device (control device) is commercially available. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | SOLITAIREâ„¢ Device | The SOLITAIREâ„¢ Device (investigational device) is the experimental arm |
| BG001 | MERCI® Device | The MERCI® Device (control device) is commercially available. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Recanalization [Thrombolysis in Myocardial Infarction (TIMI) 2 or 3] Without Symptomatic Intracranial Hemorrhage | Successful arterial recanalization of occluded target vessel measured by Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following the use of the SOLITAIRE™ or MERCI® Device without any symptomatic intracranial hemorrhage and rescue therapy within 3 passes. Thrombolysis in Myocardial Infarction (TIMI) score describes the distal flow perfusion and revascularization before and following therapy. TIMI 0 - No perfusion (worst outcome) TIMI 1 - Perfusion past the initial occlusion, but no distal branch filling TIMI 2 - Perfusion with incomplete or slow distal branch filling TIMI 3 - Full perfusion with filling of all distal branches (best outcome) | Data was unavailable for two subjects from the randomized Solitaire and one from the randomized Merci cohort. Thus, the Core Lab evaluated data from 56 in the Solitaire FR group and 54 in the Merci group. | Posted | Number | Percent of Subjects | Immediately post treatment |
|
90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
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 | The SOLITAIREâ„¢ Device | The SOLITAIREâ„¢ Device (investigational device) is the experimental arm |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | Covidien | 9498373700 |
Not provided
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| MERCI® Device | Device | The MERCI® Device is the control device that will be used in the interventional procedure. |
|
Good neurological outcome, defined as modified Rankin scale (mRS) ≤ 2, or equal to the prestroke mRS if the prestroke mRS was higher than 2, or National Institutes of Health Stroke Scale (NIHSS) score improvement of 10 points or more
| 30 Days Follow-up |
| Good Neurological Outcome 90 Days | Good neurological outcome, defined as modified Rankin scale (mRS) ≤ 2, or equal to the prestroke mRS if the prestroke mRS was higher than 2, or National Institutes of Health Stroke Scale (NIHSS) score improvement of 10 points or more | 90 Days Follow-up |
| Mortality | Rate of Mortality | 90 Days follow-up |
| Symptomatic Intracranial Hemorrhage | Symptomatic hemorrhage within 24 hours of procedure. Symptomatic hemorrhages is 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 worsening of National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24hrs. | 24 hours |
| Non-fatal Stroke-related Morbidity | Morbidity data is presented in terms of subjects with permanent deficit as a result of one or more adverse events | 90 Day |
| Tacoma |
| Washington |
| 98405 |
| United States |
| 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. |
| 26658447 | Derived | Kim JT, Jahan R, Saver JL; SWIFT Investigators. Impact of Glucose on Outcomes in Patients Treated With Mechanical Thrombectomy: A Post Hoc Analysis of the Solitaire Flow Restoration With the Intention for Thrombectomy Study. Stroke. 2016 Jan;47(1):120-7. doi: 10.1161/STROKEAHA.115.010753. Epub 2015 Dec 10. |
| 25676147 | Derived | Sheth SA, Jahan R, Levy EI, Jovin TG, Baxter B, Nogueira RG, Clark W, Budzik R, Zaidat OO, Saver JL; SWIFT Trialists. Rapid learning curve for Solitaire FR stent retriever therapy: evidence from roll-in and randomised patients in the SWIFT trial. J Neurointerv Surg. 2016 Apr;8(4):347-52. doi: 10.1136/neurintsurg-2014-011627. Epub 2015 Feb 12. |
| 24876081 | Derived | Liebeskind DS, Jahan R, Nogueira RG, Zaidat OO, Saver JL; SWIFT Investigators. Impact of collaterals on successful revascularization in Solitaire FR with the intention for thrombectomy. Stroke. 2014 Jul;45(7):2036-40. doi: 10.1161/STROKEAHA.114.004781. Epub 2014 May 29. |
| 24525954 | Derived | Liebeskind DS, Jahan R, Nogueira RG, Jovin TG, Lutsep HL, Saver JL; SWIFT Investigators. Serial Alberta Stroke Program early CT score from baseline to 24 hours in Solitaire Flow Restoration with the Intention for Thrombectomy study: a novel surrogate end point for revascularization in acute stroke. Stroke. 2014 Mar;45(3):723-7. doi: 10.1161/STROKEAHA.113.003914. Epub 2014 Feb 13. |
| 22932715 | Derived | Saver JL, Jahan R, Levy EI, Jovin TG, Baxter B, Nogueira RG, Clark W, Budzik R, Zaidat OO; SWIFT Trialists. Solitaire flow restoration device versus the Merci Retriever in patients with acute ischaemic stroke (SWIFT): a randomised, parallel-group, non-inferiority trial. Lancet. 2012 Oct 6;380(9849):1241-9. doi: 10.1016/S0140-6736(12)61384-1. Epub 2012 Aug 26. |
| ev3, Inc. | View source |
| Withdrawal by Subject |
|
| Physician Decision |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| SOLITAIREâ„¢ Device |
The SOLITAIREâ„¢ Device (investigational device) is the experimental arm |
| OG001 | MERCI® Device | The MERCI® Device (control device) is commercially available. |
|
|
| Secondary | Time to Initial Recanalization | Time from guide catheter placement to first visualization of Thrombolysis in Myocardial Infarction (TIMI) 2 flow | Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size | Posted | Mean | Standard Deviation | minutes | post treatment |
|
|
|
| Secondary | Good Neurological Outcome at 30 Days | Good neurological outcome, defined as modified Rankin scale (mRS) ≤ 2, or equal to the prestroke mRS if the prestroke mRS was higher than 2, or National Institutes of Health Stroke Scale (NIHSS) score improvement of 10 points or more | Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size. | Posted | Number | Percent of subjects | 30 Days Follow-up |
|
|
|
| Secondary | Good Neurological Outcome 90 Days | Good neurological outcome, defined as modified Rankin scale (mRS) ≤ 2, or equal to the prestroke mRS if the prestroke mRS was higher than 2, or National Institutes of Health Stroke Scale (NIHSS) score improvement of 10 points or more | Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size. | Posted | Number | Percent of subjects | 90 Days Follow-up |
|
|
|
| Secondary | Mortality | Rate of Mortality | Intent-to-treat | Posted | Number | Percentage of subjects | 90 Days follow-up |
|
|
|
| Secondary | Symptomatic Intracranial Hemorrhage | Symptomatic hemorrhage within 24 hours of procedure. Symptomatic hemorrhages is 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 worsening of National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24hrs. | Intent to treat | Posted | Number | Percentage of subjects | 24 hours |
|
|
|
| Secondary | Non-fatal Stroke-related Morbidity | Morbidity data is presented in terms of subjects with permanent deficit as a result of one or more adverse events | Intent-to-treat | Posted | Number | percentage of subjects | 90 Day |
|
|
|
| Primary | Study Device-related Serious Adverse Events (SAEs) | Incidence of study device-related Serious Adverse Events (SAEs) | Intent-to-treat | Posted | Number | percentage of subjects | 90 Day |
|
|
|
| Primary | Procedure-related Serious Adverse Events (SAEs) | Incidence of study procedure-related Serious Adverse Events (SAEs) | Intent-to-treat | Posted | Number | percentage of subjects | 90 Day |
|
|
|
| 49 |
| 58 |
| 37 |
| 58 |
| EG001 | The MERCI® Device | The MERCI® Device (control device) is commercially available. | 44 | 55 | 30 | 55 |
| Atrial Fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Retinal Artery Occlusion | Eye disorders | MedDRA | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Catheter site haematoma | General disorders | MedDRA | Systematic Assessment |
|
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Air embolism | Vascular disorders | MedDRA | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Disseminated Intravascular Coagulation | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Atrial Flutter | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Artrioventricular block | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Bradycardyia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Bundle branch block right | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac disorders | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Acute myocardial | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Mitral valve disease | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Vitreous detachment | Eye disorders | MedDRA | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrointestinal ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Device breakage | General disorders | MedDRA | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Tracheobronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Infusion site infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Febrile infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Clostridal infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bacterial disease carrier | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Procedural hypertension | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Femoral nerve injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Heart rate irregular | Investigations | MedDRA | Systematic Assessment |
|
| Electrocardiogram abnormal | Investigations | MedDRA | Systematic Assessment |
|
| Echocardiogram abnormal | Investigations | MedDRA | Systematic Assessment |
|
| Lipids increased | Investigations | MedDRA | Systematic Assessment |
|
| Breath sounds abnormal | Investigations | MedDRA | Systematic Assessment |
|
| Blood creatinine | Investigations | MedDRA | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Carotid artery dissection | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebral artery occlusion | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebral gas embolism | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebral haematoma | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebrovascular spasm | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Haemorrhagic cerebral infarction | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Intracranial pressure increased | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Intraventricular haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Increased bronchial secretion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Femoral artery occlusion | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Intra-abdominal haemorrhage | Vascular disorders | MedDRA | Systematic Assessment |
|
| Peripheral ischaemia | Vascular disorders | MedDRA | Systematic Assessment |
|
| Vasospasm | Vascular disorders | MedDRA | Systematic Assessment |
|
| Vessel perforation | Vascular disorders | MedDRA | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Catheter Site Haemorrhage | General disorders | MedDRA | Systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA | Systematic Assessment |
|
| Periorbital haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Sinus Bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiomegaly | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA | Systematic Assessment |
|
| Eye oedema | Eye disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Catheter site haematoma | General disorders | MedDRA | Systematic Assessment |
|
| Catheter site haemorrhage | General disorders | MedDRA | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Unintentional medical device removal by patient | General disorders | MedDRA | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Clostridial infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Vascular Pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Urinary retention postoperative | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA | Systematic Assessment |
|
| Differential white blood cell count abnormal | Investigations | MedDRA | Systematic Assessment |
|
| Ejection fraction decreased | Investigations | MedDRA | Systematic Assessment |
|
| Laboratory test abnormal | Investigations | MedDRA | Systematic Assessment |
|
| Low density lipoprotein increased | Investigations | MedDRA | Systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA | Systematic Assessment |
|
| Prothrombin time prolonged | Investigations | MedDRA | Systematic Assessment |
|
| Troponin increased | Investigations | MedDRA | Systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Upper extremity mass | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Carotid artery dissection | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebral haematoma | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Haemorrhagic cerebral infarction | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Intracranial pressure increased | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Intraventricular haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Muscle spasticity | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Oliguria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Genital rash | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hpoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory alkalosis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Labile blood pressure | Vascular disorders | MedDRA | Systematic Assessment |
|
| Thromophlebitis superficial | Vascular disorders | MedDRA | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Hypoventilation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
Physician shall not make any publication without providing Sponsor 30 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 |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |