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The purpose of the Trevo® Retriever Registry is to collect real world performance data of the Trevo Retriever which is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.
Trevo Retriever Registry is a prospective, open-label, consecutive enrollment, multi-center, international registry that may enroll a maximum of 2000 patients at up to 100 sites worldwide. Revascularization status will be assessed at the end of the procedure using the modified TICI (Thrombolysis in Cerebral Infarction)score. Additional data collection will include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mechanical thrombectomy, Trevo Retriever | Mechanical thrombectomy, Trevo Retriever |
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| Measure | Description | Time Frame |
|---|---|---|
| Revascularization Status Assessment at the End of the Trevo Retriever Procedure Using the Modified TICI Score | The primary end point is revascularization based on modified Thrombolysis in Cerebral Infarction score (mTICI). Per protocol, successful revascularization is defined as having a modified TICI score ≥2b at the end of the procedure. Modified TICI Scale (mTICI Scale) Grade 0 - No Perfusion Grade 1 - Penetration with Minimal Perfusion Grade 2 - Partial Perfusion Grade 2a - Only partial filling (< 50%) of the entire vascular territory is visualized. Grade 2b - Filling of > 50% all of the expected vascular territory is visualized, but the filling is slower than normal. Grade 3 - Complete Perfusion | Post Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Scale (mRS) Assessment at 90 Days | The Modified Rankin Scale 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. A good clinical outcome = mRS scale 0-2. 0 - No symptoms at all.
|
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Inclusion Criteria:
Exclusion Criteria:
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Acute ischemic stroke patients who may be referred for mechanical thrombectomy is used to removed thrombus in the neurovasculature
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| Name | Affiliation | Role |
|---|---|---|
| Erol Veznedaroglu, MD | Drexel Neurosciences Institute,Philadelphia | Principal Investigator |
| Ronald Budzik, MD | Riverside Methodist Hospital/ Ohio Health Research Institute, Columbus, OH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Desert Medical Center | Mesa | Arizona | 85202 | United States | ||
| St. Joseph's Hospital and Medical Center - Dignity Health (BNI Phoenix) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41585922 | Derived | Bartolini B, Krajina A, Budzik R, Gupta R, Nogueira RG, Malek A, Sarraj A, English J, Narata AP, Taqi M, Miller T, Grobelny T, Baxter B, Jenkins P, Liebeskind DS, Veznedaroglu E; Trevo Registry Investigators. Outcomes of Mechanical Thrombectomy of Acute Basilar Artery Occlusion Due to Underlying Intracranial Atherosclerotic Disease. Stroke Vasc Interv Neurol. 2022 Nov 18;3(2):e000429. doi: 10.1161/SVIN.122.000429. eCollection 2023 Mar. | |
| 33430634 |
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The Trevo Retriever Registry was a prospective, open-label, consecutive enrollment, multi-center international registry designed to enroll up to 2,000 subjects at up to 100 clinical sites worldwide.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mechanical Thrombectomy, Trevo Retriever | The Trevo Retriever registry was a prospective, open-label, consecutive enrollment, multi-center global registry to assess real world performance of the Trevo Retriever which is intended to restore blood flow in the neurovasculature be removing thrombus in subjects experiencing ischemic stroke |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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 | Mar 24, 2016 | Dec 6, 2018 |
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| 90 days |
| All Cause Mortality | Overall mortality rate | 90 days |
| Device and Procedure Related Serious Adverse Events (SAEs) | Rate of Device and Procedure related serious adverse events (SAE) | 90 days |
| Neurological Deterioration at 24 Hours | Neurological Deterioration at 24 hours post procedure, defined as a 4 point or more increase in the NIHSS score over the baseline score. | 24 hours |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Eden Medical Center | Castro Valley | California | 94546 | United States |
| St. Jude Medical Center | Fullerton | California | 92835 | United States |
| Scripps Memorial Hospital | La Jolla | California | 92037 | United States |
| UCLA Medical Center | Los Angeles | California | 90095 | United States |
| UCI Medical Center | Orange | California | 92868 | United States |
| California Pacific Medical Center (CPMC) | San Francisco | California | 94114 | United States |
| Good Samaritan Hospital Regional Medical Center | San Jose | California | 95124 | United States |
| Los Robles Hospital and Medical Center | Thousand Oaks | California | 91360 | United States |
| Yale University / Yale-New Haven Hospital | New Haven | Connecticut | 06520 | United States |
| Christiana Hospital | Newark | Delaware | 19718 | United States |
| Memorial Regional Hospital | Hollywood | Florida | 33021 | United States |
| Baptist Medical Center - Jacksonville | Jacksonville | Florida | 32207 | United States |
| University of Miami (Jackson Memorial) | Miami | Florida | 33126 | United States |
| Florida Hospital | Orlando | Florida | 32803 | United States |
| Center for Advanced Research Excellence (St. Mary's Medical Center) | West Palm Beach | Florida | 33409 | United States |
| Emory University at Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States |
| WellStar Kennestone Hospital | Marietta | Georgia | 30060 | United States |
| Advocate Christ Lutheran Hospital | Park Ridge | Illinois | 60068 | United States |
| Peoria Radiology Research & Education Foundation | Peoria | Illinois | 61637 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Maine Medical Center | Portland | Maine | 04102 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| UMass Memorial | Worcester | Massachusetts | 01655 | United States |
| McLaren Flint Regional Medical Center | Flint | Michigan | 48532 | United States |
| St. Joseph Mercy | Pontiac | Michigan | 48341 | United States |
| Capital Health System | Trenton | New Jersey | 08638 | United States |
| Buffalo General Medical Center | Buffalo | New York | 14203 | United States |
| Mount Sinai Health System | New York | New York | 10029 | United States |
| Vassar Brothers Medical Center | Poughkeepsie | New York | 12601 | United States |
| Mission Hospital | Asheville | North Carolina | 28801 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Riverside Methodist Hospital/ Ohio Health Research Institute | Columbus | Ohio | 43214 | United States |
| Oregon Stroke Center, Oregon Health & Science University (OHSU) | Portland | Oregon | 97239 | United States |
| Abington Memorial Hospital | Abington | Pennsylvania | 19001 | United States |
| Drexel University | Philadelphia | Pennsylvania | 19107 | United States |
| UPMC Presbyterian | Pittsburgh | Pennsylvania | 15213 | United States |
| Erlanger Hospital | Chattanooga | Tennessee | 37377 | United States |
| University of Tennessee Medical Center Knoxville | Knoxville | Tennessee | 37920 | United States |
| Methodist Healthcare - Memphis Hospitals | Memphis | Tennessee | 38120 | United States |
| Valley Baptist Harlingen | Harlingen | Texas | 78550 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| Toronto Western Hospital | Toronto | M5T 2S8 | Canada |
| University Hospital Hradec Králové | Hradec Králové | 50005 | Czechia |
| CHU Bordeaux | Bordeaux | 33000 | France |
| Hôpital Henri Mondor | Créteil | 94000 | France |
| GRENOBLE | Grenoble | 38700 | France |
| CHU Lille | Lille | 59037 | France |
| Hopital Dupuytren | Limoges | 59037 | France |
| CHU Nancy | Nancy | 54035 | France |
| La Pitié Salpêtrière | Paris | 75013 | France |
| La Fondation Ophtalmologique Adolphe de Rothschild | Paris | 75019 | France |
| CHU de Tours | Tours | 37044 | France |
| Klinikum Augsburg | Augsburg | 86156 | Germany |
| Vivantes Klinikum Neukölln | Berlin | 12351 | Germany |
| Klinikum Dortmund | Dortmund | 44137 | Germany |
| Uniklinik Erlangen | Erlangen | 91504 | Germany |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Uniklinik Heidelberg | Heidelberg | 69120 | Germany |
| Uniklinik Homburg | Homburg/ Saar | 66421 | Germany |
| UKSH; Lübeck | Lübeck | 23538 | Germany |
| Uniklinik Mainz- Mainz | Mainz-GE | 55101 | Germany |
| National Institute of Clinical Neurosciences | Budapest | 1145 | Hungary |
| Spedali Civili di Brescia | Brescia | 25123 | Italy |
| Ospedale San Martino | Genova | 16132 | Italy |
| National Neuroscience Institute, | Singapore | 308433 | Singapore |
| Kyungpook National University Hospital | Jungni I Gu | 700-721 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 463-707 | South Korea |
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Universitario Donostia | Donostia / San Sebastian | 20014 | Spain |
| Hospital Universitario De La Princesa | Madrid | 28006 | Spain |
| Hospital Universitario Central De Asturias | Oviedo | 33006 | Spain |
| Son Espases de Mallorca | Palma de Mallorca | 7120 | Spain |
| Kantonsspital Aarau | Aarau | 5000 | Switzerland |
| Siriraj Hospital | Bangkok | 10700 | Thailand |
| Derived |
| Nogueira RG, Haussen DC, Liebeskind D, Jovin TG, Gupta R, Jadhav A, Budzik RF, Baxter B, Krajina A, Bonafe A, Malek A, Narata AP, Shields R, Zhang Y, Morgan P, Bartolini B, English J, Frankel MR, Veznedaroglu E; Trevo Registry and DAWN Trial Investigators. Stroke Imaging Selection Modality and Endovascular Therapy Outcomes in the Early and Extended Time Windows. Stroke. 2021 Jan;52(2):491-497. doi: 10.1161/STROKEAHA.120.031685. Epub 2021 Jan 12. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Trevo Retriever | Mechanical thrombectomy, Trevo Retriever |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Baseline demographics included in the intent to treat population. | Count of Participants | Participants |
| |||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Revascularization Status Assessment at the End of the Trevo Retriever Procedure Using the Modified TICI Score | The primary end point is revascularization based on modified Thrombolysis in Cerebral Infarction score (mTICI). Per protocol, successful revascularization is defined as having a modified TICI score ≥2b at the end of the procedure. Modified TICI Scale (mTICI Scale) Grade 0 - No Perfusion Grade 1 - Penetration with Minimal Perfusion Grade 2 - Partial Perfusion Grade 2a - Only partial filling (< 50%) of the entire vascular territory is visualized. Grade 2b - Filling of > 50% all of the expected vascular territory is visualized, but the filling is slower than normal. Grade 3 - Complete Perfusion | Intention to Treat (ITT) | Posted | Count of Participants | Participants | Post Procedure |
|
|
| ||||||||||||||||||||||||||
| Secondary | Modified Rankin Scale (mRS) Assessment at 90 Days | The Modified Rankin Scale 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. A good clinical outcome = mRS scale 0-2. 0 - No symptoms at all.
| Per Protocol. This endpoint includes patient with a baseline and 90 day assessment. 1997 participants that underwent mechanical thrombectomy with the Trevo retriever completed both assessments. | Posted | Count of Participants | Participants | 90 days |
|
| |||||||||||||||||||||||||||
| Secondary | All Cause Mortality | Overall mortality rate | Intention to Treat (ITT) | Posted | Count of Participants | Participants | 90 days |
|
|
| ||||||||||||||||||||||||||
| Secondary | Device and Procedure Related Serious Adverse Events (SAEs) | Rate of Device and Procedure related serious adverse events (SAE) | Intention to Treat (ITT) | Posted | Count of Participants | Participants | 90 days |
|
| |||||||||||||||||||||||||||
| Secondary | Neurological Deterioration at 24 Hours | Neurological Deterioration at 24 hours post procedure, defined as a 4 point or more increase in the NIHSS score over the baseline score. | Intention to Treat | Posted | Count of Participants | Participants | 24 hours |
|
|
90 days
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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 | Mechanical Thrombectomy, Trevo Retriever | The Trevo Retriever registry was a prospective, open-label, consecutive enrollment, multi-center global registry to assess real world performance of the Trevo Retriever which is intended to restore blood flow in the neurovasculature be removing thrombus in subjects experiencing ischemic stroke | 280 | 2,008 | 427 | 2,008 | 174 | 2,008 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Acute myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Angina pectoris | Cardiac disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Atrial septal defect | Cardiac disorders | Systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac disorder | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure acute | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure congestive | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac valve disease | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac ventricular thrombosis | Cardiac disorders | Systematic Assessment |
| ||
| Cardio respiratory arrest | Cardiac disorders | Systematic Assessment |
| ||
| Cardiopulmonary failure | Cardiac disorders | Systematic Assessment |
| ||
| Intracardiac thrombus | Cardiac disorders | Systematic Assessment |
| ||
| Mitral valve incompetence | Cardiac disorders | Systematic Assessment |
| ||
| Mitral valve stenosis | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Palpitations | Cardiac disorders | Systematic Assessment |
| ||
| Pulseless electrical activity | Cardiac disorders | Systematic Assessment |
| ||
| Sick sinus syndrome | Cardiac disorders | Systematic Assessment |
| ||
| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Ventricular fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Factor V Leiden mutation | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Intestinal ichaemia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Intestinal perforation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Perirectal abscess | Gastrointestinal disorders | Systematic Assessment |
| ||
| Small intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Small intestinal perforation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Autonomic nervous system imbalance | General disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Death | General disorders | Systematic Assessment |
| ||
| Delirium tremens | General disorders | Systematic Assessment |
| ||
| General physical health deterioration | General disorders | Systematic Assessment |
| ||
| Multi-organ failure | General disorders | Systematic Assessment |
| ||
| Organ failure | General disorders | Systematic Assessment |
| ||
| Liver abscess | Hepatobiliary disorders | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Cholecystitis infective | Infections and infestations | Systematic Assessment |
| ||
| Cholstridium difficule infection | Infections and infestations | Systematic Assessment |
| ||
| Endocarditis | Infections and infestations | Systematic Assessment |
| ||
| Incision site infection | Infections and infestations | Systematic Assessment |
| ||
| Lung infection | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Pseudomonal bacteraemia | Infections and infestations | Systematic Assessment |
| ||
| Pyelonephritis acute | Infections and infestations | Systematic Assessment |
| ||
| Respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Septic shock | Infections and infestations | Systematic Assessment |
| ||
| Staphylococcal infections | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Arteriovenous fistula site haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Complications of transplanted heart | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Overdose | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Subdural haematoma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Traumatic intracranial hemmorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vascular procedure complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vascular pseudoneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vessel perforation | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Haemoglobin decreased | Investigations | Systematic Assessment |
| ||
| International normalised ratio abnormal | Investigations | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Failure to thrive | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypovolaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Metabolic acidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Gliblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Mestastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Neoplasm prostate | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Basilar artery occlusion | Nervous system disorders | Systematic Assessment |
| ||
| Brain death | Nervous system disorders | Systematic Assessment |
| ||
| Brain herniation | Nervous system disorders | Systematic Assessment |
| ||
| Brain oedema | Nervous system disorders | Systematic Assessment |
| ||
| Carotid artery occlusion | Nervous system disorders | Systematic Assessment |
| ||
| Carotid artery stenosis | Nervous system disorders | Systematic Assessment |
| ||
| Cerebral artery embolism | Nervous system disorders | Systematic Assessment |
| ||
| Cerebral artery occlusion | Nervous system disorders | Systematic Assessment |
| ||
| Cerebral artery thrombosis | Nervous system disorders | Systematic Assessment |
| ||
| Cerebral haematoma | Nervous system disorders | Systematic Assessment |
| ||
| Cerebral haemorrhage | Nervous system disorders | Systematic Assessment |
| ||
| Cerebral hyperperfusion syndrome | Nervous system disorders | Systematic Assessment |
| ||
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
| ||
| Coma | Nervous system disorders | Systematic Assessment |
| ||
| Complex partial seizures | Nervous system disorders | Systematic Assessment |
| ||
| Convulsion | Nervous system disorders | Systematic Assessment |
| ||
| Dementia | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Facial paralysis | Nervous system disorders | Systematic Assessment |
| ||
| Gasping syndrome | Nervous system disorders | Systematic Assessment |
| ||
| Haemorrhage intracranial | Nervous system disorders | Systematic Assessment |
| ||
| Haemorrhagic stroke | Nervous system disorders | Systematic Assessment |
| ||
| Haemorrhagic transformation stroke | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Intraventricular haemorrhage | Nervous system disorders | Systematic Assessment |
| ||
| Ischaemic stroke | Nervous system disorders | Systematic Assessment |
| ||
| Neurological decompensation | Nervous system disorders | Systematic Assessment |
| ||
| Partial seizures | Nervous system disorders | Systematic Assessment |
| ||
| Presyncope | Nervous system disorders | Systematic Assessment |
| ||
| Sedation | Nervous system disorders | Systematic Assessment |
| ||
| Seizure | Nervous system disorders | Systematic Assessment |
| ||
| Stroke in evolution | Nervous system disorders | Systematic Assessment |
| ||
| Transient Ischaemic attach | Nervous system disorders | Systematic Assessment |
| ||
| Vasogenic cerebral oedema | Nervous system disorders | Systematic Assessment |
| ||
| Mental status changes | Psychiatric disorders | Systematic Assessment |
| ||
| Haematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal failure acute | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal impairment | Renal and urinary disorders | Systematic Assessment |
| ||
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Asphyxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Emphysema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Obstructive airways 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 |
| ||
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Homicide | Social circumstances | Systematic Assessment |
| ||
| Mitral valve replacement | Surgical and medical procedures | Systematic Assessment |
| ||
| Artery dissection | Vascular disorders | Systematic Assessment |
| ||
| Cardiogenic shock | Vascular disorders | Systematic Assessment |
| ||
| Cerebral artery embolism | Vascular disorders | Systematic Assessment |
| ||
| Cerebral artery thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Cerebral haematoma | Vascular disorders | Systematic Assessment |
| ||
| Cerebral infarction | Vascular disorders | Systematic Assessment |
| ||
| Coeliac artery stenosis | Vascular disorders | Systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Extravasation blood | Vascular disorders | Systematic Assessment |
| ||
| Haematoma | Vascular disorders | Systematic Assessment |
| ||
| Haemorrhage | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Peripheral ischaemia | Vascular disorders | Systematic Assessment |
| ||
| Shock | Vascular disorders | Systematic Assessment |
| ||
| Subarachnoid haemorrhage | Vascular disorders | Systematic Assessment |
| ||
| Syncope | Vascular disorders | Systematic Assessment |
| ||
| Vascular dissection | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Normachromic normocytic anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Atrioventricular block | Cardiac disorders | Systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure congestive | Cardiac disorders | Systematic Assessment |
| ||
| Pulmonary oedema | Cardiac disorders | Systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Eye inflammation | Eye disorders | Systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Colitis ulcerative | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Rectal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Swollen tongue | Gastrointestinal disorders | Systematic Assessment |
| ||
| Extravasation | General disorders | Systematic Assessment |
| ||
| Tobacco withdrawal symptoms | General disorders | Systematic Assessment |
| ||
| Vessel puncture site haematoma | General disorders | Systematic Assessment |
| ||
| Drug hypersenitivity | Immune system disorders | Systematic Assessment |
| ||
| Hypersensitivity | Immune system disorders | Systematic Assessment |
| ||
| Abscess | Infections and infestations | Systematic Assessment |
| ||
| Bacteraemia | Infections and infestations | Systematic Assessment |
| ||
| Herpes virus infection | Infections and infestations | Systematic Assessment |
| ||
| Hypersensitivity | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia pseudomonal | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Post procedural haematoma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vascular procedure complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vessel perforation | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Blood pressure increased | Investigations | Systematic Assessment |
| ||
| Gout | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperlipidaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Magnesium metabolism disorder | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Metabolic acidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Gouty arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Intracranial germ cell tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Basal ganglia infarction | Nervous system disorders | Systematic Assessment |
| ||
| Carotid artery occlusion | Nervous system disorders | Systematic Assessment |
| ||
| Cerebral artery embolism | Nervous system disorders | Systematic Assessment |
| ||
| Cerebral haematoma | Nervous system disorders | Systematic Assessment |
| ||
| Cerebral infarction | Nervous system disorders | Systematic Assessment |
| ||
| Cerebral vasoconstriction | Nervous system disorders | Systematic Assessment |
| ||
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
| ||
| Confusional state | Nervous system disorders | Systematic Assessment |
| ||
| Convulsion | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Epilepsy | Nervous system disorders | Systematic Assessment |
| ||
| Haemorrhage intracranial | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Hydrocephalus | Nervous system disorders | Systematic Assessment |
| ||
| Intracranial pressure increased | Nervous system disorders | Systematic Assessment |
| ||
| Intraventricular haemorrhage | 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 |
| ||
| Anuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Dysuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Haematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Lung consolidation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Lung disorder | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Artery dissection | Vascular disorders | Systematic Assessment |
| ||
| Cerebral artery embolism | Vascular disorders | Systematic Assessment |
| ||
| Cerebral artery thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Cerebral haemorrhage | Vascular disorders | Systematic Assessment |
| ||
| Haemorrhage intracranial | Vascular disorders | Systematic Assessment |
| ||
| Haemorrhagic transformation stroke | Vascular disorders | Systematic Assessment |
| ||
| Mouth haemorrhages | Vascular disorders | Systematic Assessment |
| ||
| Subarachnoid haemorrhage | Vascular disorders | Systematic Assessment |
| ||
| Uterine haemorrhage | Vascular disorders | Systematic Assessment |
| ||
| Vascular dissection | Vascular disorders | Systematic Assessment |
| ||
| Pyrexia | General 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Minyi Ji, Biostatistician, Clinical Evidence | Stryker Neurovascular | +1 (510) 980-5689 | minyi.ji@stryker.com |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
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| United States |
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| Czechia |
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| Italy |
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| France |
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| Thailand |
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| Switzerland |
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| Spain |
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