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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-02

Study Completion Date

2023-12-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Endovascular Treatment and RIPC in Acute Ischemic Stroke

NCT04581759

Acute Ischemic Stroke Endovascular Treatment

UNKNOWN NA

Carotid Artery Stenting During Endovascular Treatment of Acute Stroke

NCT06511089

Stroke, Acute Stroke, Ischemic Carotid Stenosis +2 more

RECRUITING PHASE3

Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Stroke Patients

NCT05122637

Acute Ischemic Stroke

COMPLETED NA

Analysis of Revascularization in Ischemic Stroke With EmboTrap

NCT02488915

Stroke Ischemia

COMPLETED NA

FIrst-Pass Reperfusion With the NeVa Stent-Retriever Trial

NCT04072367

Acute Ischemic Stroke

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Ischemic Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

NOVIS Transcarotid Neuroprotection System (NPS)

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NOVIS Transcarotid Neuroprotection System (NPS)

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No