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Sponsor decided to terminate study early solely due to slow enrollment.
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Study Objective is to establish the feasibility and safety of the NOVIS Transcarotid Neuroprotection System when used for the transcarotid intervention of patients that have a failed transfemoral endovascular therapy in the case of anterior circulation strokes due to large vessel embolic occlusions.
This is a prospective, multi-center, single arm feasibility study for the endovascular treatment of patients with acute ischemic anterior circulation strokes due to large vessel embolic occlusions using the transcarotid approach with flow reversal. Patients enrolled into the NITE 1 Study will have failed transfemoral therapy and will be followed immediately from post-op to 90 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOVIS Transcarotid Neuroprotection System (NPS) | Experimental | Patients that have failed transfemoral endovascular therapy in the case of anterior circulation strokes due to large vessel embolic occlusions will enrolled in the study and treated using the NOVIS Transcarotid NPS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOVIS Transcarotid Neuroprotection System (NPS) | Device | The NOVIS Transcarotid Neuroprotection System (NPS) is intended to provide transcarotid vascular access and embolic protection |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Device-related Serious Adverse Events | The primary outcome measure assesses the number of vascular complications which include which include dissection, pseudoaneurysm, hematoma, arteriovenous fistula, thrombus formation, embolization and any vascular complication that may be attributed to the device AND requires surgical repair, surgical wound revision, transfusion, etc. The endpoint is measured at 90 days post-procedure. | 90 Days |
| Number of Other Serious Adverse Events | The primary outcome measure assesses the number of permanent cranial nerve injury, new symptomatic ipsilateral hemorrhage and dissections related to ancillary devices. The endpoint is measured at 90 days post-procedure. | 90 Days |
| Number of Subjects With Functional Independence | Functional independence will be evaluated by assessing the modified Rankin scale (mRS). The mRS comprises six levels from 0 to 5 of increasing severe disability with an additional level 6 indicating death. A lower score indicates a better outcome and a higher score indicates a worse outcome. A mRS score reported between 0 to 2 will be considered functionally independent and 3 to 6 to not be functionally independent or dead at point of measurement. The endpoint is measured at 90 days post-procedure. | 90 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Carotid Access Time | The endpoint measures the hospital arrival to neck incision, neck incision to carotid exposure, neck incision to carotid exposure, neck incision to carotid artery catheterization which includes the securement of the sheath, neck incision to femoral venous sheath access which includes the securement of the sheath, and neck incision to initiation of reverse flow. | Hospital arrival to neck incision, neck incision to carotid exposure, neck incision to carotid exposure, neck incision to carotid artery catheterization, neck incision to femoral venous sheath access which, and neck incision to initiation of reverse flow. |
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Inclusion Criteria Summary:
1. Patients presenting with acute ischemic stroke of the anterior circulation with large vessel occlusions who are eligible for revascularization using endovascular therapies (stentrievers and/or aspiration devices)
2. Occlusion of the intracranial ICA, MCA M1, proximal MCA M2, single-vessel MCA M2, dominant MCA M2, or co-dominant MCA M2 segments
3. Patient has failed transfemoral therapy (see Appendix 4 for definition), and at least 15 minutes have elapsed from groin puncture
Exclusion Criteria Summary:
1. Significant disease of the ipsilateral common carotid artery on routine CTA
2. Presence of a cervical ICA loop or other high-risk anatomical features of the ICA on routine CTA, that may preclude the use of the NOVIS NPS
3. Any active or recent hemorrhage within the past 30 days
4. Embolectomy contraindications
a. Pre-stroke mRS ≥2 b. NIHSS ≤ 5 c. ASPECTS ≤ 5
5. IV tPA has been or is being administered
6. Last known well > 24 hours ago
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| Name | Affiliation | Role |
|---|---|---|
| Charles Matouk, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06511 | United States |
IPD will not be shared
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| ID | Title | Description |
|---|---|---|
| FG000 | NOVIS Transcarotid Neuroprotection System (NPS) | Patients that have failed transfemoral endovascular therapy in the case of anterior circulation strokes due to large vessel embolic occlusions will enrolled in the study and treated using the NOVIS Transcarotid NPS. NOVIS Transcarotid Neuroprotection System (NPS): The NOVIS Transcarotid Neuroprotection System (NPS) is intended to provide transcarotid vascular access and embolic protection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NOVIS Transcarotid Neuroprotection System (NPS) | Patients that have failed transfemoral endovascular therapy in the case of anterior circulation strokes due to large vessel embolic occlusions will enrolled in the study and treated using the NOVIS Transcarotid NPS. NOVIS Transcarotid Neuroprotection System (NPS): The NOVIS Transcarotid Neuroprotection System (NPS) is intended to provide transcarotid vascular access and embolic protection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Device-related Serious Adverse Events | The primary outcome measure assesses the number of vascular complications which include which include dissection, pseudoaneurysm, hematoma, arteriovenous fistula, thrombus formation, embolization and any vascular complication that may be attributed to the device AND requires surgical repair, surgical wound revision, transfusion, etc. The endpoint is measured at 90 days post-procedure. | Posted | Number | device-related serious adverse events | 90 Days |
|
Adverse event data were collected up to 90 days follow up post procedure
Subjects who underwent the NOVIS Transcarotid NPS are included in the analysis set. Subjects who did not undergo the NOVIS Transcarotid NPS are excluded from analysis.
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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 | NOVIS Transcarotid Neuroprotection System (NPS) | Patients that have failed transfemoral endovascular therapy in the case of anterior circulation strokes due to large vessel embolic occlusions will enrolled in the study and treated using the NOVIS Transcarotid NPS. NOVIS Transcarotid Neuroprotection System (NPS): The NOVIS Transcarotid Neuroprotection System (NPS) is intended to provide transcarotid vascular access and embolic protection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | MedDRA 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
Sponsor decided to terminate study early solely due to slow enrollment leading to small number of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Smith | Silk Road Medical | 763-335-5160 | hsmith@silkroadmed.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 15, 2023 | Dec 10, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 31, 2024 | Dec 10, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Patients with acute ischemic anterior circulation stroke due to large vessel embolic occlusion who are candidates for endovascular therapy and in whom transfemoral therapy failed.
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| Time to Final Revascularization | The endpoint measures the time of hospital arrival to operating room (OR), last known well to final revascularization, admission to final revascularization, OR to final revascularization, Cutdown to final revascularization, arterial introduction of interventional tools to final revascularization, total reverse flow time including common carotid artery (CCA) clamp to CCA unclamp. | Hospital arrival to OR, LKW to final revascularization, admission to final revascularization, OR to final revascularization, cutdown to final revascularization, arterial introduction of interventional tools to final revascularization, total reverse flow. |
| Number of Device-Related Complications | This outcome measure assesses the number of reported complications that may be attributed to the device through the end of all patient follow up in the study. | 90 Days |
| Neurologic Assessment | The outcome measure measures neurological worsening of patients according to the National Institutes of Health Stroke Scale (NIHSS) at 90 days post procedure. The NIHSS is a graded neurological examination that assesses consciousness, eye movements, visual fields, motor and sensory impairments, ataxia, speech, cognition and inattention. The NIHSS is a combination of 11 components each with a particular scale as follows: level of consciousness (1a: 0-3, 1b: 0-2 and 1c: 0-2), best gaze (0-2), visual fields (0-3), facial palsy (0-3), arm motor (0-4), leg motor (0-4), limb ataxia (0-2), sensory (0-2), best language (0-3), dysarthria (0-2), extinction and inattention (0-2). The components are summed, and a lower score indicates better outcomes, and higher score indicates worse outcomes. A neurological worsening similar to a non-disabling stroke is considered scored less than or equal to 4 and a neurological worsening similar to a disabling stroke with a score equal to or greater than 5. | 90 Days |
| Technical Sucess Rate | The outcome measure will count the number patients with successful introduction of endovascular tools through the NOVIS Transcarotid NPS during the procedure. Introduction of endovascular tools will be considered successful if NPS was placed, reverse flow was established, and interventional tools were successfully delivered. | Start to end of index procedure |
| Revascularization Sucess Rate | The outcome measure reports the number of patients with modified thrombolysis in cerebral infarction (mTICI) score evaluated by the contract core lab measuring angiograms collected from baseline to immediately after the end of the index procedure. The mTICI grading scale is a tool for determining the response of thrombolytic therapy for ischemic stroke on a scale between 0 to 3. A lower score indicates better outcomes and higher score indicates worse outcomes The score 2 has two additional grades of severity of 2a and 2b indicating worse outcomes along the alphabetical progression of the scale. | Start to end of index procedure |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Number of Other Serious Adverse Events | The primary outcome measure assesses the number of permanent cranial nerve injury, new symptomatic ipsilateral hemorrhage and dissections related to ancillary devices. The endpoint is measured at 90 days post-procedure. | Posted | Number | other serious adverse events | 90 Days |
|
|
|
| Primary | Number of Subjects With Functional Independence | Functional independence will be evaluated by assessing the modified Rankin scale (mRS). The mRS comprises six levels from 0 to 5 of increasing severe disability with an additional level 6 indicating death. A lower score indicates a better outcome and a higher score indicates a worse outcome. A mRS score reported between 0 to 2 will be considered functionally independent and 3 to 6 to not be functionally independent or dead at point of measurement. The endpoint is measured at 90 days post-procedure. | Posted | Count of Participants | Participants | 90 Days |
|
|
|
| Secondary | Carotid Access Time | The endpoint measures the hospital arrival to neck incision, neck incision to carotid exposure, neck incision to carotid exposure, neck incision to carotid artery catheterization which includes the securement of the sheath, neck incision to femoral venous sheath access which includes the securement of the sheath, and neck incision to initiation of reverse flow. | Posted | Mean | Standard Deviation | minutes | Hospital arrival to neck incision, neck incision to carotid exposure, neck incision to carotid exposure, neck incision to carotid artery catheterization, neck incision to femoral venous sheath access which, and neck incision to initiation of reverse flow. |
|
|
|
| Secondary | Time to Final Revascularization | The endpoint measures the time of hospital arrival to operating room (OR), last known well to final revascularization, admission to final revascularization, OR to final revascularization, Cutdown to final revascularization, arterial introduction of interventional tools to final revascularization, total reverse flow time including common carotid artery (CCA) clamp to CCA unclamp. | Posted | Mean | Standard Deviation | minutes | Hospital arrival to OR, LKW to final revascularization, admission to final revascularization, OR to final revascularization, cutdown to final revascularization, arterial introduction of interventional tools to final revascularization, total reverse flow. |
|
|
|
| Secondary | Number of Device-Related Complications | This outcome measure assesses the number of reported complications that may be attributed to the device through the end of all patient follow up in the study. | Posted | Number | complications | 90 Days |
|
|
|
| Secondary | Neurologic Assessment | The outcome measure measures neurological worsening of patients according to the National Institutes of Health Stroke Scale (NIHSS) at 90 days post procedure. The NIHSS is a graded neurological examination that assesses consciousness, eye movements, visual fields, motor and sensory impairments, ataxia, speech, cognition and inattention. The NIHSS is a combination of 11 components each with a particular scale as follows: level of consciousness (1a: 0-3, 1b: 0-2 and 1c: 0-2), best gaze (0-2), visual fields (0-3), facial palsy (0-3), arm motor (0-4), leg motor (0-4), limb ataxia (0-2), sensory (0-2), best language (0-3), dysarthria (0-2), extinction and inattention (0-2). The components are summed, and a lower score indicates better outcomes, and higher score indicates worse outcomes. A neurological worsening similar to a non-disabling stroke is considered scored less than or equal to 4 and a neurological worsening similar to a disabling stroke with a score equal to or greater than 5. | Posted | Count of Participants | Participants | 90 Days |
|
|
|
| Secondary | Technical Sucess Rate | The outcome measure will count the number patients with successful introduction of endovascular tools through the NOVIS Transcarotid NPS during the procedure. Introduction of endovascular tools will be considered successful if NPS was placed, reverse flow was established, and interventional tools were successfully delivered. | Posted | Count of Participants | Participants | Start to end of index procedure |
|
|
|
| Secondary | Revascularization Sucess Rate | The outcome measure reports the number of patients with modified thrombolysis in cerebral infarction (mTICI) score evaluated by the contract core lab measuring angiograms collected from baseline to immediately after the end of the index procedure. The mTICI grading scale is a tool for determining the response of thrombolytic therapy for ischemic stroke on a scale between 0 to 3. A lower score indicates better outcomes and higher score indicates worse outcomes The score 2 has two additional grades of severity of 2a and 2b indicating worse outcomes along the alphabetical progression of the scale. | Posted | Count of Participants | Participants | Start to end of index procedure |
|
|
|
| 3 |
| 12 |
| 9 |
| 12 |
| 12 |
| 12 |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Increased bronchial secretion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Embolic stroke | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Reperfusion injury | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| Gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| End stage renal disease | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Basal ganglia stroke | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Stress cardiomyopathy | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Fluid overload | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Normal pressure hydrocephalus | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Asymptomatic COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cytotoxic edema | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypernatremia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypercalcemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Genital injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Atrial enlargement | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| Clostridium difficile infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Spinal column injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Metabolic encephalopathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hemorrhagic transformation stroke | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hyperphosphatemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| Urine output decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Carotid artery dissection | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypophosphatemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Administration site hematoma | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Aortic stenosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cerebral hemorrhage | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Ejection fraction decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Skin injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
|
| Neck incision to femoral venous sheath access (includes securement of sheath) |
|
| Neck incision to initiation of reverse flow |
|
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| Operating room to final reperfusion |
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| Cutdown to final reperfusion |
|
| Arterial introduction of interventional tools to final reperfusion |
|
| Total reverse flow time (CCA clamp to CCA unclamp) |
|