NPS for Ischemic Stroke
(NITE1 Trial)

Overseen BySenior Director Clinical Affairs

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Silk Road Medical

Must not be taking: IV tPA

Disqualifiers: Carotid disease, Hemorrhage, Embolectomy contraindications, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial tests a new device that protects the brain by changing blood flow direction in patients with certain types of strokes who did not respond to usual treatments. The new method is being assessed as an alternative way to protect the brain during a specific procedure.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are currently receiving IV tPA (a clot-busting medication), you would not be eligible for this trial.

What data supports the effectiveness of the NOVIS Transcarotid Neuroprotection System treatment for ischemic stroke?

Research on neuroprotective treatments, like those used in ischemic stroke, shows promise in protecting brain cells from damage. Although no single treatment has proven effective in clinical trials, combining therapies and improving trial designs have renewed hope for successful outcomes.¹ ² ³ ⁴ ⁵

How is the NOVIS Transcarotid Neuroprotection System treatment different from other treatments for ischemic stroke?

The NOVIS Transcarotid Neuroprotection System is unique because it likely involves a novel approach to neuroprotection, potentially using nanoparticles (tiny particles that can cross the blood-brain barrier) to deliver treatment directly to the brain, which is different from the standard clot-busting drug alteplase that has a limited time window and can cause bleeding complications.⁴ ⁶ ⁷ ⁸ ⁹

Research Team

Charles Matouk, MD

Principal Investigator

Yale University

Eligibility Criteria

Inclusion Criteria

You have a type of severe stroke in the front part of the brain and are able to have a specific type of treatment using devices to remove blockages in blood vessels.

You have a blockage in certain blood vessels in your brain.

You have already tried a certain type of therapy through the leg, and at least 15 minutes have passed since a needle was inserted into your groin.

Exclusion Criteria

Your routine CTA shows a special shape or features of your cervical ICA that may make it difficult to use the NOVIS NPS.

You have received or are currently receiving a medicine called IV tPA.

A major health issue in the main artery on one side of your neck, as seen on a regular CTA scan.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Patients receive the NOVIS Transcarotid Neuroprotection System treatment after failed transfemoral therapy for acute ischemic stroke

Immediate procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of adverse events and functional independence

90 days

Multiple visits (in-person and virtual)

Treatment Details

Interventions

NOVIS Transcarotid Neuroprotection System

Participant Groups

1Treatment groups

Experimental Treatment

Group I: NOVIS Transcarotid Neuroprotection System (NPS)Experimental Treatment1 Intervention

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.