NPS for Ischemic Stroke

(NITE1 Trial)

Overseen By Senior 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 Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the NOVIS Transcarotid Neuroprotection System for individuals who have experienced an ischemic stroke due to a blocked artery in the brain. The trial aims to determine if this device is safe and effective when other treatments, such as catheter-based methods through the groin, have failed. It suits those who have had a stroke in the front part of the brain and have not succeeded with other artery-clearing methods. As an unphased trial, it provides a unique opportunity to contribute to groundbreaking research and potentially benefit from an innovative treatment.

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 prior data suggests that the NOVIS Transcarotid Neuroprotection System is safe for transcarotid intervention?

Research has shown that the NOVIS Transcarotid Neuroprotection System (NPS) is generally safe for patients who have had strokes. Other studies have found that using NPS during stroke treatment carries a low risk of causing complications such as another stroke or heart issues afterward. In past uses, patients have tolerated the system well. The treatment aims to assist patients who haven't benefited from other stroke procedures, offering a safe and promising alternative. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the NOVIS Transcarotid Neuroprotection System (NPS) because it offers a novel approach to treating ischemic stroke, particularly in patients who have not benefited from traditional transfemoral endovascular therapy. Unlike standard treatments that generally involve accessing the brain's blood vessels through the femoral artery in the leg, the NOVIS system uses a transcarotid approach, directly accessing the carotid artery in the neck. This method may provide improved protection and efficiency in removing blockages in large vessel occlusions, potentially leading to better outcomes for patients who have anterior circulation strokes. This innovative delivery method could represent a significant advancement in stroke care, especially for those who have limited options after conventional treatments fail.

What evidence suggests that the NOVIS Transcarotid Neuroprotection System is effective for ischemic stroke?

Research has shown that the NOVIS Transcarotid Neuroprotection System (NPS), which trial participants will receive, protects the brain during certain strokes by reversing blood flow in the carotid artery. This method helps prevent further brain damage when standard treatments fail. Studies have found that this system is safe and practical for patients with sudden strokes. Results suggest that using the NOVIS system can reduce the risk of additional strokes and heart issues after the procedure. The device's unique approach to altering blood flow direction offers a promising new option for stroke patients who haven't benefited from other treatments. ^{1 2 3 4 6}

Who Is on the Research Team?

Charles Matouk, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• NOVIS Transcarotid Neuroprotection System

How Is the Trial Designed?

Group I: NOVIS Transcarotid Neuroprotection System (NPS) Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Silk Road Medical

Lead Sponsor

Trials

10

Recruited

1,900+

Citations

1. withpower.com withpower.com/trial/phase-ischemic-stroke-9-2021-7e55d

NPS for Ischemic Stroke (NITE1 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 ...

2. studypages.com studypages.com/s/acute-ischemic-stroke-treatment-study-using-the-novis-transcarotid-neuroprotection-system-887357/

Acute Ischemic Stroke Treatment Study Using the NOVIS ... The purpose of this study is to evaluate the safety and feasibility of the NOVIS Transcarotid NPS device when used for transcarotid mechanical thrombectomy.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04881162/feasibility-study-of-the-treatment-of-acute-ischemic-stroke-using-the-novis-transcarotid-neuroprotection-system

Feasibility Study of the Treatment of Acute Ischemic Stroke ... Study Objective is to establish the feasibility and safety of the NOVIS Transcarotid Neuroprotection System when used for the transcarotid ...

4. cms.gov cms.gov/medicarecoverageideapproved-ide-studies/g200347-nct04881162

G200347-NCT04881162 Study Title. Feasibility Study of the Treatment of Acute Ischemic Stroke Using the NOVIS Transcarotid Neuroprotection System In Transcarotid Embolectomy.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0741521418319839

Outcomes associated with a transcarotid artery ... We report that dynamic reverse-flow TCAR using the ENPS continues to be safe, feasible, and efficacious with minimal risks of postoperative stroke, myocardial ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9673728/

Perioperative and 1‐Year Rates of Stroke or Death TCAR appears to be a safe alternative to CEA and TF‐CAS when used selectively and may be useful when treating symptomatic patients.