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

Acute Ischemic Stroke Clinical Trial

— NITE1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04881162
• Other study ID #: SRM-2019-01
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2021
• Est. completion date: December 2023

Study information

• Verified date: April 2022
• Source: Silk Road Medical
• Contact: Clinical Affairs Manager
• Phone: 408-585-2142
• Email: nhaque[@]silkroadmed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Device:
• NOVIS Transcarotid Neuroprotection System (NPS)
The NOVIS Transcarotid Neuroprotection System (NPS) is intended to provide transcarotid vascular access and embolic protection

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Silk Road Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	procedure to 90 days
Primary	Other Serious Adverse Events	Permanent cranial nerve injury, new symptomatic ipsilateral hemorrhage and dissections related to ancillary devices	procedure to 90 days
Primary	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)	90 days