Trial Outcomes & Findings for Feasibility Study of the Treatment of Acute Ischemic Stroke Using the NOVIS Transcarotid Neuroprotection System (NCT NCT04881162)

Last Updated: 2025-01-17

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

90 Days

Results posted on

2025-01-17

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility Study of the Treatment of Acute Ischemic Stroke Using the NOVIS Transcarotid Neuroprotection System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NOVIS Transcarotid Neuroprotection System (NPS) n=12 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 90 Days

Outcome measures

Outcome measures
Measure	NOVIS Transcarotid Neuroprotection System (NPS) n=12 Participants 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
Number of Device-related Serious Adverse Events	0 device-related serious adverse events

PRIMARY outcome

Timeframe: 90 Days

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.

Outcome measures

Outcome measures
Measure	NOVIS Transcarotid Neuroprotection System (NPS) n=12 Participants 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
Number of Other Serious Adverse Events	0 other serious adverse events

PRIMARY outcome

Timeframe: 90 Days

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.

Outcome measures

Outcome measures
Measure	NOVIS Transcarotid Neuroprotection System (NPS) n=12 Participants 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
Number of Subjects With Functional Independence mRS of 0 to 2	4 Participants
Number of Subjects With Functional Independence mRS of 3 to 6	8 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	NOVIS Transcarotid Neuroprotection System (NPS) n=12 Participants 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
Carotid Access Time Hospital arrival to neck incision	100.3 minutes Standard Deviation 40.6
Carotid Access Time Neck incision to carotid exposure	13.5 minutes Standard Deviation 5.0
Carotid Access Time Neck incision to carotid catheterization (includes securement of sheath)	20.4 minutes Standard Deviation 7.5
Carotid Access Time Neck incision to femoral venous sheath access (includes securement of sheath)	6.8 minutes Standard Deviation 11.9
Carotid Access Time Neck incision to initiation of reverse flow	35 minutes Standard Deviation 13.2

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	NOVIS Transcarotid Neuroprotection System (NPS) n=12 Participants 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
Time to Final Revascularization Hospital arrival to operating room	46.7 minutes Standard Deviation 41.9
Time to Final Revascularization Last known well to final reperfusion	628.9 minutes Standard Deviation 336.0
Time to Final Revascularization Admission to final reperfusion	156.7 minutes Standard Deviation 32.0
Time to Final Revascularization Operating room to final reperfusion	110.0 minutes Standard Deviation 43.05
Time to Final Revascularization Cutdown to final reperfusion	56.3 minutes Standard Deviation 25.1
Time to Final Revascularization Arterial introduction of interventional tools to final reperfusion	22.0 minutes Standard Deviation 24.2
Time to Final Revascularization Total reverse flow time (CCA clamp to CCA unclamp)	20.3 minutes Standard Deviation 26.2

SECONDARY outcome

Timeframe: 90 Days

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.

Outcome measures

Outcome measures
Measure	NOVIS Transcarotid Neuroprotection System (NPS) n=12 Participants 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
Number of Device-Related Complications	1 complications

SECONDARY outcome

Timeframe: 90 Days

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.

Outcome measures

Outcome measures
Measure	NOVIS Transcarotid Neuroprotection System (NPS) n=12 Participants 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
Neurologic Assessment Non-Disabling Stroke (NIHSS ≤ 4)	8 Participants
Neurologic Assessment Disabling Stroke (NIHSS ≥ 5	4 Participants

SECONDARY outcome

Timeframe: Start to end of index procedure

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.

Outcome measures

Outcome measures
Measure	NOVIS Transcarotid Neuroprotection System (NPS) n=12 Participants 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
Technical Sucess Rate Technical Sucess Achieved	12 Participants
Technical Sucess Rate Technical Sucess Not Achieved	0 Participants

SECONDARY outcome

Timeframe: Start to end of index procedure

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.

Outcome measures

Outcome measures
Measure	NOVIS Transcarotid Neuroprotection System (NPS) n=12 Participants 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
Revascularization Sucess Rate mTICI score 2b	10 Participants
Revascularization Sucess Rate mTICI score 3	2 Participants

Adverse Events

NOVIS Transcarotid Neuroprotection System (NPS)

Serious events: 9 serious events

Other events: 12 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	NOVIS Transcarotid Neuroprotection System (NPS) n=12 participants at risk 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
General disorders Death	25.0% 3/12 • Number of events 3 • 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.
Respiratory, thoracic and mediastinal disorders Hypoxia	16.7% 2/12 • Number of events 2 • 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.
Respiratory, thoracic and mediastinal disorders Increased bronchial secretion	8.3% 1/12 • Number of events 1 • 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.
Infections and infestations Pneumonia	8.3% 1/12 • Number of events 1 • 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.
Nervous system disorders Embolic stroke	8.3% 1/12 • Number of events 1 • 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.
Injury, poisoning and procedural complications Fall	8.3% 1/12 • Number of events 1 • 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.
Vascular disorders Reperfusion injury	8.3% 1/12 • Number of events 1 • 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.
Vascular disorders Hypertension	8.3% 1/12 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	8.3% 1/12 • Number of events 1 • 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.
Blood and lymphatic system disorders Anemia	8.3% 1/12 • Number of events 1 • 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.
Gastrointestinal disorders Gastrointestinal hemorrhage	8.3% 1/12 • Number of events 1 • 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.
Renal and urinary disorders End stage renal disease	8.3% 1/12 • Number of events 1 • 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.
Cardiac disorders Bradycardia	8.3% 1/12 • Number of events 1 • 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.
Nervous system disorders Cerebrovascular accident	8.3% 1/12 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	8.3% 1/12 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Pleural effusion	8.3% 1/12 • Number of events 1 • 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.
Infections and infestations Cellulitis	8.3% 1/12 • Number of events 1 • 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.
Nervous system disorders Basal ganglia stroke	8.3% 1/12 • Number of events 1 • 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.
Cardiac disorders Stress cardiomyopathy	8.3% 1/12 • Number of events 1 • 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.
Nervous system disorders Syncope	8.3% 1/12 • Number of events 1 • 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.
Psychiatric disorders Mental status changes	8.3% 1/12 • Number of events 1 • 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.

Other adverse events

Other adverse events
Measure	NOVIS Transcarotid Neuroprotection System (NPS) n=12 participants at risk 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
Blood and lymphatic system disorders Leukocytosis	25.0% 3/12 • Number of events 3 • 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.
Renal and urinary disorders Acute kidney injury	25.0% 3/12 • Number of events 3 • 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.
Infections and infestations Urinary tract infection	25.0% 3/12 • Number of events 3 • 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.
Psychiatric disorders Delirium	16.7% 2/12 • Number of events 2 • 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.
Renal and urinary disorders Urinary incontinence	16.7% 2/12 • Number of events 2 • 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.
Metabolism and nutrition disorders Hyperkalemia	16.7% 2/12 • Number of events 2 • 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.
Vascular disorders Hypotension	16.7% 2/12 • Number of events 2 • 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.
Gastrointestinal disorders Constipation	16.7% 2/12 • Number of events 2 • 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.
Gastrointestinal disorders Dysphagia	16.7% 2/12 • Number of events 2 • 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.
Infections and infestations Pneumonia	16.7% 2/12 • Number of events 2 • 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.
Respiratory, thoracic and mediastinal disorders Hypoxia	16.7% 2/12 • Number of events 2 • 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.
Renal and urinary disorders Hematuria	16.7% 2/12 • Number of events 2 • 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.
Gastrointestinal disorders Diarrhea	16.7% 2/12 • Number of events 2 • 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.
Metabolism and nutrition disorders Fluid overload	16.7% 2/12 • Number of events 2 • 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.
Metabolism and nutrition disorders Hyperglycemia	16.7% 2/12 • Number of events 2 • 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.
Blood and lymphatic system disorders Anemia	16.7% 2/12 • Number of events 2 • 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.
Vascular disorders Hypertension	8.3% 1/12 • Number of events 2 • 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.
Infections and infestations Oral candidiasis	8.3% 1/12 • Number of events 1 • 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.
General disorders Asthenia	8.3% 1/12 • Number of events 1 • 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.
Nervous system disorders Normal pressure hydrocephalus	8.3% 1/12 • Number of events 1 • 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.
Infections and infestations Asymptomatic COVID-19	8.3% 1/12 • Number of events 1 • 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.
Vascular disorders Thrombosis	8.3% 1/12 • Number of events 1 • 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.
Nervous system disorders Cytotoxic edema	8.3% 1/12 • Number of events 1 • 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.
Metabolism and nutrition disorders Hypernatremia	8.3% 1/12 • Number of events 1 • 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.
Metabolism and nutrition disorders Hypercalcemia	8.3% 1/12 • Number of events 1 • 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.
Injury, poisoning and procedural complications Genital injury	8.3% 1/12 • Number of events 1 • 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.
Metabolism and nutrition disorders Hypoglycemia	8.3% 1/12 • Number of events 1 • 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.
Cardiac disorders Atrial enlargement	8.3% 1/12 • Number of events 1 • 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.
Infections and infestations Clostridium difficile infection	8.3% 1/12 • Number of events 1 • 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.
Injury, poisoning and procedural complications Spinal column injury	8.3% 1/12 • Number of events 1 • 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.
Psychiatric disorders Insomnia	8.3% 1/12 • Number of events 1 • 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.
Nervous system disorders Metabolic encephalopathy	8.3% 1/12 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Petechiae	8.3% 1/12 • Number of events 1 • 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.
Nervous system disorders Hemorrhagic transformation stroke	8.3% 1/12 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Aspiration	8.3% 1/12 • Number of events 1 • 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.
Metabolism and nutrition disorders Hypomagnesemia	8.3% 1/12 • Number of events 1 • 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.
Metabolism and nutrition disorders Hyperphosphatemia	8.3% 1/12 • Number of events 1 • 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.
Cardiac disorders Tachycardia	8.3% 1/12 • Number of events 1 • 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.
Investigations Urine output decreased	8.3% 1/12 • Number of events 1 • 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.
Gastrointestinal disorders Dyspepsia	8.3% 1/12 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	8.3% 1/12 • Number of events 1 • 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.
Nervous system disorders Carotid artery dissection	8.3% 1/12 • Number of events 1 • 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.
Cardiac disorders Acute myocardial infarction	8.3% 1/12 • Number of events 1 • 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.
Metabolism and nutrition disorders Hypophosphatemia	8.3% 1/12 • Number of events 1 • 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.
General disorders Administration site hematoma	8.3% 1/12 • Number of events 1 • 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.
Vascular disorders Aortic stenosis	8.3% 1/12 • Number of events 1 • 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.
Nervous system disorders Cerebral hemorrhage	8.3% 1/12 • Number of events 1 • 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.
Investigations Ejection fraction decreased	8.3% 1/12 • Number of events 1 • 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.
Metabolism and nutrition disorders Hypokalemia	8.3% 1/12 • Number of events 1 • 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.
Injury, poisoning and procedural complications Skin injury	8.3% 1/12 • Number of events 1 • 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.

Additional Information

Heather Smith

Silk Road Medical

Phone: 763-335-5160

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place