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Neuroprotection System

NPS for Ischemic Stroke (NITE1 Trial)

N/A
Recruiting
Led By Charles Matouk, MD
Research Sponsored by Silk Road Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Patient has failed transfemoral therapy (see Appendix 4 for definition), and at least 15 minutes have elapsed from groin puncture
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

NITE1 Trial Summary

This trial is to see if a new neuroprotection system is safe and feasible to use for people who have had a failed transfemoral endovascular therapy for anterior circulation strokes.

Eligible Conditions
  • Stroke

NITE1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
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.
Select...
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.

NITE1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Device-related Serious Adverse Events
Functional independence at 90-days
Other Serious Adverse Events

NITE1 Trial Design

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.

Find a Location

Who is running the clinical trial?

Silk Road MedicalLead Sponsor
8 Previous Clinical Trials
1,508 Total Patients Enrolled
Charles Matouk, MDPrincipal InvestigatorYale University

Media Library

NOVIS Transcarotid Neuroprotection System (Neuroprotection System) Clinical Trial Eligibility Overview. Trial Name: NCT04881162 — N/A
Stroke Research Study Groups: NOVIS Transcarotid Neuroprotection System (NPS)
Stroke Clinical Trial 2023: NOVIS Transcarotid Neuroprotection System Highlights & Side Effects. Trial Name: NCT04881162 — N/A
NOVIS Transcarotid Neuroprotection System (Neuroprotection System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04881162 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently opportunities to participate in this research?

"As indicated by clinicaltrials.gov, enrolment is currently open for this medical trial. It was initially posted on November 2nd 2021 and recently revised on November 30th 2022."

Answered by AI

How many individuals have been accepted into this clinical experiment?

"Affirmative. Using the clinicaltrials.gov platform, we can confirm that this medical trial is actively looking for participants to join its ranks. It was first posted on November 2nd 2021 and last updated on November 30th 2022; presently it requires registration from thirty patients at a single location."

Answered by AI
~9 spots leftby Mar 2025