Back to resultsFeasibility Study of the Treatment of Acute Ischemic Stroke Using the NOVIS Transcarotid Neuroprotection System (NITE1)
Primary Purpose
Acute Ischemic Stroke
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NOVIS Transcarotid Neuroprotection System (NPS)
Sponsored by
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring mechanical thrombectomy, stroke treatment, embolic protection, transcarotid
Eligibility Criteria
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
Sites / Locations
- Yale UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NOVIS Transcarotid Neuroprotection System (NPS)
Arm Description
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.
Outcomes
Primary Outcome Measures
Device-related Serious Adverse Events
Vascular complications including 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.
Other Serious Adverse Events
Permanent cranial nerve injury, new symptomatic ipsilateral hemorrhage and dissections related to ancillary devices
Functional independence at 90-days
modified Rankin scale score 0-2 (out of a maximum scale of 6. A lower score indicates better outcome, a higher score indicates worse outcome)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04881162
Brief Title
Feasibility Study of the Treatment of Acute Ischemic Stroke Using the NOVIS Transcarotid Neuroprotection System
Acronym
NITE1
Official Title
Feasibility Study of the Treatment of Acute Ischemic Stroke Using the NOVIS Transcarotid Neuroprotection System In Transcarotid Embolectomy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Silk Road Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
mechanical thrombectomy, stroke treatment, embolic protection, transcarotid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NOVIS Transcarotid Neuroprotection System (NPS)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
NOVIS Transcarotid Neuroprotection System (NPS)
Intervention Description
The NOVIS Transcarotid Neuroprotection System (NPS) is intended to provide transcarotid vascular access and embolic protection
Primary Outcome Measure Information:
Title
Device-related Serious Adverse Events
Description
Vascular complications including 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.
Time Frame
procedure to 90 days
Title
Other Serious Adverse Events
Description
Permanent cranial nerve injury, new symptomatic ipsilateral hemorrhage and dissections related to ancillary devices
Time Frame
procedure to 90 days
Title
Functional independence at 90-days
Description
modified Rankin scale score 0-2 (out of a maximum scale of 6. A lower score indicates better outcome, a higher score indicates worse outcome)
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Affairs Manager
Phone
408-585-2142
Email
nhaque@silkroadmed.com
First Name & Middle Initial & Last Name or Official Title & Degree
Senior Director Clinical Affairs
Phone
669-271-0501
Email
dsahoo@silkroadmed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Matouk, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsey Fraczkiewicz
Phone
203-785-3490
Email
lindsey.fraczkiewicz@yale.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared
Learn more about this trial
Feasibility Study of the Treatment of Acute Ischemic Stroke Using the NOVIS Transcarotid Neuroprotection System
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