Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study objective is to examine the recanalization efficacy of the EmboTrap device and its associated performance characteristics and to record associated clinical outcomes in a manner that facilitates relevant comparison of outputs with that of devices approved in the U.S. for clearing Large Vessel Occlusions.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EmboTrap® Revascularization Device | Experimental | Mechanical Thrombectomy with EmboTrap |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EmboTrap® Revascularization Device | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful Revascularization Measured Using Modified Thrombolysis in Cerebrovascular Infarction (mTICI Inclusive of the 2c Rating) | Successful achievement of the endpoint is defined as achieving an mTICI score of 2b or greater in the target vessel following 3 or less passes of the EmboTrap device. Patients treated with rescue prior to completion of three passes with EmboTrap were treated as failures to meet the primary revascularization endpoint. (Post measurement of the primary endpoint some patients subsequently received additional treatment.) - mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke: mTICI 0 = No perfusion mTICI 1 = Penetration but not perfusion mTICI 2a = Some perfusion with distal branch filling of <50% of territory visualized mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized mTICI 2c = Near-complete perfusion mTICI 3 = Complete perfusion | Post-treatment |
| Occurrence of Symptomatic Intracerebral Hemorrhage (sICH) Within 24 Hours Post-procedure and Any Other Serious Adverse Device Effects (SADE) | The primary safety endpoint will be measured as the occurrence of Symptomatic Intracerebral hemorrhage (sICH) within 24 hours (-8/+12 hrs) post-procedure, together with any other Serious Adverse Device Effects (excluding those already counted in sICH). sICH was assessed using the Heidelberg Bleeding Classification, i.e. any intracerebral hemorrhage associated with an increase of ≥4 points in the NIHSS scale or an increase of ≥2 points of a NIHSS subcategory or that leads to major medical intervention. SADE was categorized as any serious adverse event that was deemed to be caused by the study device. | 24(-8/+12 hrs) hours post-procedure and 90(±14) days Post Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Good Clinical Outcome as Defined by Modified Rankin Scale (mRS) Score ≤2 | Good Clinical Outcome is defined as achieving an mRS score of ≤2 at 90 days post procedure. - mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. mRS scores range from 0 to 6: mRS 0 = No symptoms. mRS 1 = No significant disability. mRS 2 = Slight disability. mRS 3 = Moderate disability. mRS 4 = Moderately severe disability. mRS 5 = Severe disability. mRS 6 = Dead. |
Not provided
Inclusion Criteria:
The patient or the patient's legally authorized representative has signed and dated an Informed Consent Form.
Aged between 18 years and 85 years (inclusive).
A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
NIHSS score ≥8 and ≤25.
Pre-ictal mRS score of 0 or 1.
The interventionalist estimates that at least one deployment of the EmboTrap device can be completed within 8 hours from the onset of symptoms.
Patients for whom IV-tPA is indicated and who are available for treatment, are treated with IV-tPA.
IV-tPA, if used, was initiated within 3 hrs of stroke onset (onset time is defined as the last time when the patient was witnessed to be at baseline), with investigator verification that the subject has received/is receiving the correct IV t-PA dose for the estimated weight.
Angiographic confirmation of an occlusion of an ICA (including T or L occlusions), M1 or M2 MCA, VA, or BA with mTICI flow of 0 - 1.
For strokes in the anterior circulation the following imaging criteria should also be met:
The patient is indicated for neurothrombectomy treatment by the interventionalist and it is confirmed by diagnostic angiography that the device will be able to reach the target lesion proximally.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Prof. Sam Zaidat, M.D. | St. Vincent Mercy Mercy Hospital, Toledo,Ohio, USA | Principal Investigator |
| Prof. Tommy Andersson, M.D. | Karolinska Institutet | Principal Investigator |
| Prof. Jeffery Saver, M.D. | UCLA, CA, USA. | Study Director |
| Prof. Heinrich Mattle, M.D. | University of Berne, Berne, Switzerland. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Los Angeles | California | 90095 | United States | ||
| Good Samaritan Hospital and Regional Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34046008 | Derived | Yoo AJ, Soomro J, Andersson T, Saver JL, Ribo M, Bozorgchami H, Dabus G, Liebeskind DS, Jadhav A, Mattle H, Zaidat OO. Benchmarking the Extent and Speed of Reperfusion: First Pass TICI 2c-3 Is a Preferred Endovascular Reperfusion Endpoint. Front Neurol. 2021 May 11;12:669934. doi: 10.3389/fneur.2021.669934. eCollection 2021. | |
| 29643261 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | EmboTrap® Revascularization Device | Mechanical Thrombectomy with EmboTrap EmboTrap® Revascularization Device |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One subject enrolled was not treated with any thrombectomy device due to severe agitation.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | EmboTrap® Revascularization Device | Mechanical Thrombectomy with EmboTrap EmboTrap® Revascularization 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 | Successful Revascularization Measured Using Modified Thrombolysis in Cerebrovascular Infarction (mTICI Inclusive of the 2c Rating) | Successful achievement of the endpoint is defined as achieving an mTICI score of 2b or greater in the target vessel following 3 or less passes of the EmboTrap device. Patients treated with rescue prior to completion of three passes with EmboTrap were treated as failures to meet the primary revascularization endpoint. (Post measurement of the primary endpoint some patients subsequently received additional treatment.) - mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke: mTICI 0 = No perfusion mTICI 1 = Penetration but not perfusion mTICI 2a = Some perfusion with distal branch filling of <50% of territory visualized mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized mTICI 2c = Near-complete perfusion mTICI 3 = Complete perfusion | Analysis population includes all patients enrolled and treated with the EmboTrap device (N=227) irrespective of whether they met all incl/excl criteria. | Posted | Count of Participants | Participants | Post-treatment |
3 months
Not provided
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 | EmboTrap® Revascularization Device | Mechanical Thrombectomy with EmboTrap EmboTrap® Revascularization Device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| MairsÃl Claffey | Neuravi Ltd | 0035391394123 | mclaffey@neuravi.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 28, 2016 | May 17, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 13, 2017 | May 17, 2018 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D007511 | Ischemia |
| D001927 | Brain Diseases |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D000083242 | Ischemic Stroke |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 90(±14) days Post Procedure |
| Procedure Time | The time from groin puncture to achievement of mTICI ≥2b, or if not obtained, to the final angiogram. - mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke: mTICI 0 = No perfusion mTICI 1 = Penetration but not perfusion mTICI 2a = Some perfusion with distal branch filling of <50% of territory visualized mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized mTICI 2c = Near-complete perfusion mTICI 3 = Complete perfusion | Post-treatment |
| All Procedure-related Mortality | Any death that is deemed to have been caused by the study procedure. | Day 7 post-procedure |
| All-cause Mortality | Any death that occurs within 90(±14) days post-procedure. | 90(±14) days Post Procedure |
| Occurrence of Serious Adverse Device Effects (SADE) | SADE was categorized as any serious adverse event that was deemed to be caused by the study device. | 90(±14) days Post Procedure |
| Occurrence of Procedure Related Serious Adverse Events (PRSAE) | PRSAE was categorized as any serious adverse event that was deemed to be caused by the study procedure. | 90(±14) days Post Procedure |
| Occurrence of Symptomatic Intracerebral Hemorrhage (sICH) | sICH was assessed using the Heidelberg Bleeding Classification, i.e. any intracerebral hemorrhage associated with an increase of ≥4 points in the NIHSS scale or an increase of ≥2 points of a NIHSS subcategory or that leads to major medical intervention. | 24(-8/+12) hours post-procedure |
| Occurrence of Neurological Deterioration | An increase of 4 points or more on the National Institutes of Health Stroke Scale (NIHSS) at 24 hours (-8/+12 hrs) post-procedure. The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 - 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment. | 24(-8/+12) hours post-procedure |
| Proportion of Subjects With Evidence of Infarction of a Previously Uninvolved Vascular Territory | Infarction (i.e. brain tissue death) of a previously uninvolved vascular territory (i.e. region of the brain) is evaluated from 24-hour imaging (Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)). | 24(-8/+12) hours post-procedure |
| Time to Treat | The time from first baseline angiogram to achievement of mTICI ≥2b, or if not obtained, to the final angiogram. - mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke: mTICI 0 = No perfusion mTICI 1 = Penetration but not perfusion mTICI 2a = Some perfusion with distal branch filling of <50% of territory visualized mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized mTICI 2c = Near-complete perfusion mTICI 3 = Complete perfusion | Post-treatment |
| San Jose |
| California |
| 95124 |
| United States |
| University of Miami and Jackson Memorial Hospital | Miami | Florida | 33136 | United States |
| Emory University School of Medicine, | Atlanta | Georgia | 30303 | United States |
| Riverside Radiology and Interventional Associates | Columbus | Ohio | 43214 | United States |
| St Vincent Mercy Hospital | Toledo | Ohio | 43608 | United States |
| OHSU Stroke Center | Portland | Oregon | 97239 | United States |
| UPMC Stroke Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Tennessee Interventional and Imaging Associates | Chattanooga | Tennessee | 37403 | United States |
| AZ Groeninge | Kortrijk | Belgium |
| UKSH Campus Kiel | Kiel | Germany |
| Beaumont Hospital | Dublin | Ireland |
| Zaidat OO, Bozorgchami H, Ribo M, Saver JL, Mattle HP, Chapot R, Narata AP, Francois O, Jadhav AP, Grossberg JA, Riedel CH, Tomasello A, Clark WM, Nordmeyer H, Lin E, Nogueira RG, Yoo AJ, Jovin TG, Siddiqui AH, Bernard T, Claffey M, Andersson T. Primary Results of the Multicenter ARISE II Study (Analysis of Revascularization in Ischemic Stroke With EmboTrap). Stroke. 2018 May;49(5):1107-1115. doi: 10.1161/STROKEAHA.117.020125. Epub 2018 Apr 11. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| National Institutes of Health Stroke Scale (NIHSS) Score | The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 - 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment. | Mean | Standard Deviation | Scores on a scale |
|
| Pre-stroke Modified Rankin Scale (mRS) | mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. mRS scores range from 0 to 6: mRS 0 = No symptoms. mRS 1 = No significant disability. mRS 2 = Slight disability. mRS 3 = Moderate disability. mRS 4 = Moderately severe disability. mRS 5 = Severe disability. mRS 6 = Dead. | Count of Participants | Participants |
|
| BMI | BMI not recorded per standard of care at all study sites | Mean | Standard Deviation | kg per square meter |
|
| Medical History | Count of Participants | Participants |
|
| Most Proximal occlusion location | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | EmboTrap® Revascularization Device | Mechanical Thrombectomy with EmboTrap EmboTrap® Revascularization Device |
|
|
| Primary | Occurrence of Symptomatic Intracerebral Hemorrhage (sICH) Within 24 Hours Post-procedure and Any Other Serious Adverse Device Effects (SADE) | The primary safety endpoint will be measured as the occurrence of Symptomatic Intracerebral hemorrhage (sICH) within 24 hours (-8/+12 hrs) post-procedure, together with any other Serious Adverse Device Effects (excluding those already counted in sICH). sICH was assessed using the Heidelberg Bleeding Classification, i.e. any intracerebral hemorrhage associated with an increase of ≥4 points in the NIHSS scale or an increase of ≥2 points of a NIHSS subcategory or that leads to major medical intervention. SADE was categorized as any serious adverse event that was deemed to be caused by the study device. | Posted | Count of Participants | Participants | 24(-8/+12 hrs) hours post-procedure and 90(±14) days Post Procedure |
|
|
|
| Secondary | Good Clinical Outcome as Defined by Modified Rankin Scale (mRS) Score ≤2 | Good Clinical Outcome is defined as achieving an mRS score of ≤2 at 90 days post procedure. - mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. mRS scores range from 0 to 6: mRS 0 = No symptoms. mRS 1 = No significant disability. mRS 2 = Slight disability. mRS 3 = Moderate disability. mRS 4 = Moderately severe disability. mRS 5 = Severe disability. mRS 6 = Dead. | All patients enrolled and treated with the EmboTrap device for whom there is known data, including those who were subsequently treated with other therapies. However, outcome data excludes cases where the patient withdrew consent or was lost to follow up, with undefined/unknown scores. | Posted | Count of Participants | Participants | 90(±14) days Post Procedure |
|
|
|
| Secondary | Procedure Time | The time from groin puncture to achievement of mTICI ≥2b, or if not obtained, to the final angiogram. - mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke: mTICI 0 = No perfusion mTICI 1 = Penetration but not perfusion mTICI 2a = Some perfusion with distal branch filling of <50% of territory visualized mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized mTICI 2c = Near-complete perfusion mTICI 3 = Complete perfusion | Posted | Median | Inter-Quartile Range | minutes | Post-treatment |
|
|
|
| Secondary | All Procedure-related Mortality | Any death that is deemed to have been caused by the study procedure. | Posted | Count of Participants | Participants | Day 7 post-procedure |
|
|
|
| Secondary | All-cause Mortality | Any death that occurs within 90(±14) days post-procedure. | Denominator excludes missing data. Participants who were Lost to Follow-up and Withdrew Consent were treated as missing data. | Posted | Count of Participants | Participants | 90(±14) days Post Procedure |
|
|
|
| Secondary | Occurrence of Serious Adverse Device Effects (SADE) | SADE was categorized as any serious adverse event that was deemed to be caused by the study device. | Posted | Count of Participants | Participants | 90(±14) days Post Procedure |
|
|
|
| Secondary | Occurrence of Procedure Related Serious Adverse Events (PRSAE) | PRSAE was categorized as any serious adverse event that was deemed to be caused by the study procedure. | Posted | Count of Participants | Participants | 90(±14) days Post Procedure |
|
|
|
| Secondary | Occurrence of Symptomatic Intracerebral Hemorrhage (sICH) | sICH was assessed using the Heidelberg Bleeding Classification, i.e. any intracerebral hemorrhage associated with an increase of ≥4 points in the NIHSS scale or an increase of ≥2 points of a NIHSS subcategory or that leads to major medical intervention. | Posted | Count of Participants | Participants | 24(-8/+12) hours post-procedure |
|
|
|
| Secondary | Occurrence of Neurological Deterioration | An increase of 4 points or more on the National Institutes of Health Stroke Scale (NIHSS) at 24 hours (-8/+12 hrs) post-procedure. The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 - 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment. | Denominator exclude missing data. Participant who were not assessed for NIHSS at 24hrs and/or those who used rescue therapy at any time during the procedure were treated as missing data. | Posted | Count of Participants | Participants | 24(-8/+12) hours post-procedure |
|
|
|
| Secondary | Proportion of Subjects With Evidence of Infarction of a Previously Uninvolved Vascular Territory | Infarction (i.e. brain tissue death) of a previously uninvolved vascular territory (i.e. region of the brain) is evaluated from 24-hour imaging (Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)). | Posted | Count of Participants | Participants | 24(-8/+12) hours post-procedure |
|
|
|
| Secondary | Time to Treat | The time from first baseline angiogram to achievement of mTICI ≥2b, or if not obtained, to the final angiogram. - mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke: mTICI 0 = No perfusion mTICI 1 = Penetration but not perfusion mTICI 2a = Some perfusion with distal branch filling of <50% of territory visualized mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized mTICI 2c = Near-complete perfusion mTICI 3 = Complete perfusion | Posted | Median | Inter-Quartile Range | minutes | Post-treatment |
|
|
|
| Post-Hoc | Proportion of Subjects With New Territory Embolisation | Embolisation of any new territories was recorded directly post-treatment. | Posted | Count of Participants | Participants | Post-treatment |
|
|
|
| 20 |
| 227 |
| 92 |
| 227 |
| 175 |
| 227 |
| Atrial fibrillation | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Sinus node dysfunction | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cardiovascular disorder | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hyperparathyroidism primary | Endocrine disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vessel puncture site thrombosis | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vessel puncture site haemorrhage | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Vascular injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Malignant respiratory tract neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Haemorrhagic transformation stroke | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Neurological decompensation | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Carotid artery dissection | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Metabolic encephalopathy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cerebral artery occlusion | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Coronary arterial stent insertion | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
|
| Vessel perforation | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Haemorrhagic transformation stroke | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cerebral vasoconstriction | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Not provided
Not provided
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007238 | Infarction |
| D009336 | Necrosis |