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NPS for Ischemic Stroke (NITE1 Trial)
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.
- Stroke
NITE1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowNITE1 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.NITE1 Trial Design
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- 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.
- Group 1: NOVIS Transcarotid Neuroprotection System (NPS)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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