Status:
TERMINATED
Feasibility Study of the Treatment of Acute Ischemic Stroke Using the NOVIS Transcarotid Neuroprotection System
Lead Sponsor:
Silk Road Medical
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
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 endo...
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 usi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04881162
Start Date
November 2 2021
End Date
December 11 2023
Last Update
January 17 2025
Active Locations (1)
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1
Yale University
New Haven, Connecticut, United States, 06511