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

Silk Road Medical

Status: Terminated

Conditions: Acute Ischemic Stroke

Treatments: Device: NOVIS Transcarotid Neuroprotection System (NPS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04881162

SRM-2019-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

NOVIS Transcarotid Neuroprotection System (NPS)

Experimental group

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.

Treatment:

Device: NOVIS Transcarotid Neuroprotection System (NPS)