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Neuroprotection System
NPS for Ischemic Stroke (NITE1 Trial)
N/A
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
No Placebo-Only Group
Summary
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.
Eligible Conditions
- Stroke
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Device-related Serious Adverse Events
Functional independence at 90-days
Other Serious Adverse Events
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NOVIS Transcarotid Neuroprotection System (NPS)
2021
N/A
~20
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Who is running the clinical trial?
Silk Road MedicalLead Sponsor
9 Previous Clinical Trials
1,852 Total Patients Enrolled
Charles Matouk, MDPrincipal InvestigatorYale University
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Eligibility Criteria:
This trial includes the following eligibility 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.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.A major health issue in the main artery on one side of your neck, as seen on a regular CTA scan.You have had any bleeding in the last 30 days.- You have a score of 2 or higher on the pre-stroke mRS scale.
- Your NIHSS score is less than or equal to 5.
- Your ASPECTS score is less than or equal to 5.The person's last reported healthy state was more than 24 hours ago.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.
Research Study Groups:
This trial has the following groups:- Group 1: NOVIS Transcarotid Neuroprotection System (NPS)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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