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

Not Applicable

Terminated

• Conditions: Acute Ischemic Stroke
• Interventions: Device: NOVIS Transcarotid Neuroprotection System (NPS)

• Registration Number: NCT04881162
• Lead Sponsor: Silk Road Medical

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-04-30
• Study First Submitted QC: 2021-05-10
• Study First Posted: 2021-05-11
• Study Start: 2021-11-02
• Primary Completion: 2023-12-11
• Study Completion: 2023-12-11
• Results First Submitted: 2024-12-10
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-16
• Last Update Submitted: 2025-01-16
• Results First Posted: 2025-01-17
• Last Update Posted: 2025-01-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NOVIS Transcarotid Neuroprotection System (NPS)	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.

Primary Outcome Measures

Name	Time	Method
Number of Device-related Serious Adverse Events	90 Days	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.
Number of Other Serious Adverse Events	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.
Number of Subjects With Functional Independence	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.

Secondary Outcome Measures

Name	Time	Method
Carotid Access Time	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.
Time to Final Revascularization	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.
Number of Device-Related Complications	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.
Neurologic Assessment	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.
Technical Sucess Rate	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.
Revascularization Sucess Rate	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.

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States