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To evaluate the safety and efficacy of the Bard ViVEXX Carotid Stent and Emboshield BareWire Rapid Exchange Embolic Protection System in the treatment of extracranial carotid artery stenosis in patients at high risk for carotid endarterectomy.
Patients with clinically significant stenosis within the common and/or internal carotid artery who are at high risk for carotid endarterectomy and are amenable to percutaneous treatment including embolic protection, balloon angioplasty and the carotid stent placement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stent placement in the carotid artery | Experimental | placement of a bare metal stent for treatment of carotid artery stenosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carotid Artery Stenting | Device | placement of a bare metal stent at sites of stenosis in the carotid artery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Experiencing Major Adverse Events (MAE) | A composite of major adverse events (MAE) including any death, any stroke and/or myocardial infarction occurring during the first 30 days post-procedure and ipsilateral stroke between 31 and 365 days post procedure. | 365 days from implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Target Lesion Revascularization(s) (TLR) | Number of participants experiencing a Target lesion revascularization(s) up to 12 months after implantation | 12 months from implantation |
| Number of Patients Experiencing Access Site Complications |
Not provided
Inclusion Criteria:
The patient has a symptomatic or asymptomatic carotid artery stenosis that meets one of the following criteria:
High risk for carotid endarterectomy: anatomical and co-morbid.
Exclusion Criteria:
Not provided
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Rosenfield, MD | Massachusetts General Hospital | Principal Investigator |
Not provided
Each site was required to enroll at least one roll-in patient prior to commencing the pivotal phase to demonstrate appropriate training and technique. Each roll-in patient was required to meet the same eligibility criteria and follow the same follow-up schedule as the pivotal cohort. The pivotal cohort represents the intent-to-treat population.
Enrollment commenced on October 7, 2005 and was completed on November 6, 2007. A total of 486 patients from 34 investigative sites within the United States were enrolled, including 79 in the roll-in cohort and 407 in the pivotal cohort. The Roll-in cohort is intended to provide initial training and verification of procedure technique
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ViVexx Carotid Stent Group | placement of a bare metal stent for treatment of carotid artery stenosis |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ViVexx Carotid Stent Group | placement of a bare metal stent for treatment of carotid artery stenosis |
| 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 | Percentage of Patients Experiencing Major Adverse Events (MAE) | A composite of major adverse events (MAE) including any death, any stroke and/or myocardial infarction occurring during the first 30 days post-procedure and ipsilateral stroke between 31 and 365 days post procedure. | All patients who were enrolled in the pivotal cohort were analyzed as an intention to treat population. | Posted | Mean | 95% Confidence Interval | percentage of participants | 365 days from implantation |
|
|
Implantation through 12 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 | ViVexx Carotid Stent Group | placement of a bare metal stent for treatment of carotid artery stenosis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedRa 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedRa 10.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | C.R. Bard Inc. | 480-303-2644 | 2644 | john.reviere@crbard.com |
| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| D003251 | Constriction, Pathologic |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
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Access site complications requiring blood transfusion (> 1 unit) or open surgical repair. |
| 30 days following implantation |
| Number of Participants Experiencing Stroke Related Neurologic Deficit | Number of participants experiencing stroke related neurologic deficit persisting at 30 days and attributed to the index procedure. | 30 days from implantation |
| Number of Participants Experiencing Device Success | Number of participants with successful delivery and deployment of device with <50% residual stenosis. | at time of implantation |
| Number of Participants Experiencing Lesion Success | number of participants experiencing achievement of <50% final residual diameter stenosis in the stented segment using the VIVEXX Carotid Stent and the Emboshield Embolic Protection System. | at time of implantation |
| Number of Participants Experiencing Restenosis | Number of participants experiencing Restenosis following placement of the ViVexx Carotid Stent. | 12 months after implantation |
| Study device could not be deployed |
|
| years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Number of Participants Experiencing Target Lesion Revascularization(s) (TLR) | Number of participants experiencing a Target lesion revascularization(s) up to 12 months after implantation | Number of participants experiencing target lesion revascularization up to 12 months from implantation | Posted | Number | Number of participants | 12 months from implantation |
|
|
|
| Secondary | Number of Patients Experiencing Access Site Complications | Access site complications requiring blood transfusion (> 1 unit) or open surgical repair. | Number of participants experiencing access site complications requiring blood transfusion (>1 unit) or open repair. | Posted | Number | Number of participants | 30 days following implantation |
|
|
|
| Secondary | Number of Participants Experiencing Stroke Related Neurologic Deficit | Number of participants experiencing stroke related neurologic deficit persisting at 30 days and attributed to the index procedure. | Number of participants experiencing stroke related neurologic deficit persisting at 30 days and attributed to index procedure. | Posted | Number | number of participants | 30 days from implantation |
|
|
|
| Secondary | Number of Participants Experiencing Device Success | Number of participants with successful delivery and deployment of device with <50% residual stenosis. | Number of participants with successful delivery and deployment of device with <50% residual stenosis. | Posted | Number | number of participants | at time of implantation |
|
|
|
| Secondary | Number of Participants Experiencing Lesion Success | number of participants experiencing achievement of <50% final residual diameter stenosis in the stented segment using the VIVEXX Carotid Stent and the Emboshield Embolic Protection System. | number of participants with lesion success defined as <50% residual stenosis. | Posted | Number | number of participants | at time of implantation |
|
|
|
| Secondary | Number of Participants Experiencing Restenosis | Number of participants experiencing Restenosis following placement of the ViVexx Carotid Stent. | Number of participants experiencing restenosis through 12 months from implantation. | Posted | Number | number of participants | 12 months after implantation |
|
|
|
| 316 |
| 486 |
| 301 |
| 486 |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedRa 10.0 | Systematic Assessment |
|
| Splenomegaly | Blood and lymphatic system disorders | MedRa 10.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Angia unstable | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Arrythmia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Atrial Figrillation | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Arterioventricular block first degree | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedRa 10.0 | Systematic Assessment |
|
| Bundle branch block right | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cardiomegaly | Cardiac disorders | MedDRA (10.0)car | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Atrial septal defect | Congenital, familial and genetic disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Congenital arterial malformation | Congenital, familial and genetic disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Ear Pain | Ear and labyrinth disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Amaurosis fugax | Eye disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Conjunctival heamorrhage | Eye disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Eye Pain | Eye disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Gaze palsy | Eye disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Halo vision | Eye disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Macular degeneration | Eye disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Orbital oedema | Eye disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Retinal artery embolism | Eye disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Rtinal vein occlusion | Eye disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Visual impairment | Eye disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Hypothyrodism | Endocrine disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| onstipation | Gastrointestinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Diverticulum | Gastrointestinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Impaired gastric emptying | Gastrointestinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Oral disorder | Gastrointestinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Tooth impacted | Gastrointestinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Adverse drug reaction | General disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Catheter site haemorrhage | General disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedRa 10.0 | Non-systematic Assessment |
|
| chest pain | General disorders | MedRa 10.0 | Non-systematic Assessment |
|
| fatigue | General disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Gait disturbance | General disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Implant site erosion | General disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Infusion site extravasation | General disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Injection site haematoma | General disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedRa 10.0 | Non-systematic Assessment |
|
| mass | General disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedRa 10.0 | Non-systematic Assessment |
|
| Adenoviral upper respitaory infections | Infections and infestations | MedRa 10.0 | Non-systematic Assessment |
|
| Bacterial disease carrier | Infections and infestations | MedRa 10.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedRa 10.0 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedRa 10.0 | Non-systematic Assessment |
|
| Clostridial infection | Infections and infestations | MedRa 10.0 | Non-systematic Assessment |
|
| Clostridium defficile colitis | Infections and infestations | MedRa 10.0 | Non-systematic Assessment |
|
| Eye infection | Infections and infestations | MedRa 10.0 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedRa 10.0 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedRa 10.0 | Non-systematic Assessment |
|
| Labyrinthitis | Infections and infestations | MedRa 10.0 | Non-systematic Assessment |
|
| Otitis externa | Infections and infestations | MedRa 10.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedRa 10.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedRa 10.0 | Non-systematic Assessment |
|
| Skin Candida | Infections and infestations | MedRa 10.0 | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedRa 10.0 | Non-systematic Assessment |
|
| Tracheobronchitis | Infections and infestations | MedRa 10.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedRa 10.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedRa 10.0 | Non-systematic Assessment |
|
| Urinary tract infection enterococcal | Infections and infestations | MedRa 10.0 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedRa 10.0 | Non-systematic Assessment |
|
| Anaemia postoperative | Injury, poisoning and procedural complications | MedRa 10.0 | Non-systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedRa 10.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedRa 10.0 | Non-systematic Assessment |
|
| fall | Injury, poisoning and procedural complications | MedRa 10.0 | Non-systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedRa 10.0 | Non-systematic Assessment |
|
| Incisional hernia | Injury, poisoning and procedural complications | MedRa 10.0 | Non-systematic Assessment |
|
| Pelvic Fracture | Injury, poisoning and procedural complications | MedRa 10.0 | Non-systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedRa 10.0 | Non-systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedRa 10.0 | Non-systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedRa 10.0 | Non-systematic Assessment |
|
| Vascular access complication | Injury, poisoning and procedural complications | MedRa 10.0 | Non-systematic Assessment |
|
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedRa 10.0 | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedRa 10.0 | Non-systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedRa 10.0 | Non-systematic Assessment |
|
| Blood creatine phospokinase MB increased | Investigations | MedRa 10.0 | Non-systematic Assessment |
|
| Blood magnesium decreased | Investigations | MedRa 10.0 | Non-systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedRa 10.0 | Non-systematic Assessment |
|
| Full blood count decreased | Investigations | MedRa 10.0 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedRa 10.0 | Non-systematic Assessment |
|
| Heart rate decreased | Investigations | MedRa 10.0 | Non-systematic Assessment |
|
| Heart rate irregular | Investigations | MedRa 10.0 | Non-systematic Assessment |
|
| NIH stroke scale abnormal | Investigations | MedRa 10.0 | Non-systematic Assessment |
|
| Neurological examination abnormal | Investigations | MedRa 10.0 | Non-systematic Assessment |
|
| Troponin | Investigations | MedRa 10.0 | Non-systematic Assessment |
|
| Troponin increased | Investigations | MedRa 10.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Lactic acidosis | Metabolism and nutrition disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Musculskeletal pain | Musculoskeletal and connective tissue disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRa 10.0 | Non-systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRa 10.0 | Non-systematic Assessment |
|
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRa 10.0 | Non-systematic Assessment |
|
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRa 10.0 | Non-systematic Assessment |
|
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRa 10.0 | Non-systematic Assessment |
|
| Aphasia | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Areflexia | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Ataxia | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Basilar artery stenosis | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Carotid ARtery Stenosis | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| cognitive disorder | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| convulsion | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Diabetic neuropathy | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Embolic stroke | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Facial paresis | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Hemianopia | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Intracranial haematoma | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Momory impairment | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Motor dysfunction | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Nerve compression | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Sensory loss | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Syncope vasovagal | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Unresponsive to stimui | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Vertebral artery occlusion | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Bladder distension | Renal and urinary disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Oliguria | Renal and urinary disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Renal mass | Renal and urinary disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Scrotal oedema | Reproductive system and breast disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Rales | Respiratory, thoracic and mediastinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Sinus disorder | Respiratory, thoracic and mediastinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Systemic lupus erythematosus rash | Skin and subcutaneous tissue disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Aneurysm | Vascular disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedRa 10.0 | Non-systematic Assessment |
|
| arterial restenosis | Vascular disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Arterial spasm | Vascular disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Arterial stenosis | Vascular disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Arteriovenous fistula | Vascular disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Blood pressure fluctuation | Vascular disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Carotid artery dissection | Vascular disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Intermittent claudication | Vascular disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Ischaemia | Vascular disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Hypoaesthesia facial | Vascular disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Peripheral vascular disorder | Vascular disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Subclavian artery stenosis | Vascular disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Thrombosis | Vascular disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedRa 10.0 | Non-systematic Assessment |
|
| CArdiac failure congestive | Cardiac disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Mycardial infarction | Cardiac disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedRa 10.0 | Non-systematic Assessment |
|
| Cerebralvascular accident | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedRa 10.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedRa 10.0 | Non-systematic Assessment |
|
Not provided
| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |