NITE1: Feasibility Study of the Treatment of Acute Ischemic Stroke Using the NOVIS Transcarotid Neuroprotection System

• Sponsor: Silk Road Medical (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04881162
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 12.9
• Patients Per Site Per Month: 2.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke	Device: NOVIS Transcarotid Neuroprotection System (NPS)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention 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.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)
• Primary Purpose: Treatment
• Official Title: Feasibility Study of the Treatment of Acute Ischemic Stroke Using the NOVIS Transcarotid Neuroprotection System In Transcarotid Embolectomy
• Actual Study Start Date: Nov 2, 2021
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: NOVIS Transcarotid Neuroprotection System (NPS); The NOVIS Transcarotid Neuroprotection System (NPS) is intended to provide transcarotid vascular access and embolic protection

Outcome Measures

Primary Outcome Measures

1. Device-related Serious Adverse Events [procedure to 90 days]

   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.

2. Other Serious Adverse Events [procedure to 90 days]

   Permanent cranial nerve injury, new symptomatic ipsilateral hemorrhage and dissections related to ancillary devices

3. Functional independence at 90-days [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

1. Occlusion of the intracranial ICA, MCA M1, proximal MCA M2, single-vessel MCA M2, dominant MCA M2, or co-dominant MCA M2 segments

2. 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

1. 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

2. Any active or recent hemorrhage within the past 30 days

3. Embolectomy contraindications

1. Pre-stroke mRS ≥2 b. NIHSS ≤ 5 c. ASPECTS ≤ 5

1. IV tPA has been or is being administered

2. Last known well > 24 hours ago

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale University	New Haven	Connecticut	United States	06511

Sponsors and Collaborators

• Silk Road Medical

Investigators

• Principal Investigator: Charles Matouk, MD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Silk Road Medical
• ClinicalTrials.gov Identifier: NCT04881162
• Other Study ID Numbers: SRM-2019-01
• First Posted: May 11, 2021
• Last Update Posted: Apr 28, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Silk Road Medical: mechanical thrombectomy; stroke treatment; embolic protection; transcarotid
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia

Study Results

No Results Posted as of Apr 28, 2022