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Device
Aspiration Thrombectomy for Carotid Stenosis
N/A
Waitlist Available
Led By James Joye, DO
Research Sponsored by Fogarty Clinical Research Inc.
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 18-48 hours post stenting
Awards & highlights
Study Summary
This trial will test whether a thrombectomy after a carotid stent deployment can reduce the number of procedure-related signals in the brain as seen on a diffusion weighted MRI.
Who is the study for?
This trial is for adults over 40 with carotid artery stenosis who've had symptoms like a stroke or TIA in the last six months. It's not for pregnant individuals, those with asymptomatic stenosis, total occlusion, allergies to certain anti-platelet drugs, other major vessel issues, or an inability to undergo MRI.Check my eligibility
What is being tested?
The study tests if using the Emboshield NAV6 embolic protection system after placing a carotid stent can reduce brain damage signs on MRI. Participants will have this device used during their procedure to see if it offers extra protection.See study design
What are the potential side effects?
Potential side effects may include discomfort at the catheter insertion site, risk of minor bleeding due to anti-platelet medication use, and rare chances of more serious complications related to heart and blood vessels from the procedure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18-48 hours post stenting
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18-48 hours post stenting
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of new, ischemic foci
Secondary outcome measures
Ischemic zone area
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Distal Embolic Protection OnlyExperimental Treatment1 Intervention
Carotid stenting with distal embolic protection only
Group II: Distal embolic protection and aspiration thrombectomyActive Control1 Intervention
Aspiration thrombectomy following stent deployment and prior to removal of distal embolic protection
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Who is running the clinical trial?
Fogarty Clinical Research Inc.Lead Sponsor
1 Previous Clinical Trials
852 Total Patients Enrolled
Abbott Medical DevicesIndustry Sponsor
638 Previous Clinical Trials
404,108 Total Patients Enrolled
Helen Kay FoundationUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have atrial fibrillation and am not treated with warfarin or dabigatran.I currently have a bleeding disorder.I am willing to participate and provide consent.I have severe artery hardening in my upper body.I have had a major stroke, multiple small strokes, or dementia.My condition involves narrowed blood vessels with visible clots.I've had a stroke or similar event on the same side as my stented lesion in the last 6 months.I am under 40 years old.I am allergic to aspirin and drugs like clopidogrel.I have a narrowed common carotid artery.I have a severe blockage in my hip or groin blood vessels that makes certain heart procedures unsafe.The main artery in your neck is completely blocked.You are unable to have a diffusion-weighted magnetic resonance imaging (DWMRI) scan.You are expected to live for less than 30 days.You have blockages in your carotid artery that can't be treated with just one stent.I need treatment for a narrowed artery in my brain on the same side.Your blood vessels are not narrowed by more than 50% according to angiography.You have more than 50% blockage in the carotid artery.I have a brain blood vessel malformation or aneurysm needing treatment.I have a narrowed carotid artery but no symptoms.A device to protect my blood vessel during treatment cannot be used.I had a stroke or mini-stroke on the same side as my treatment area over 6 months ago.I had a suspected heart attack within 3 days before my planned neck artery stent procedure.
Research Study Groups:
This trial has the following groups:- Group 1: Distal Embolic Protection Only
- Group 2: Distal embolic protection and aspiration thrombectomy
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there any availability for participants in this clinical investigation?
"According to the records hosted on clinicaltrials.gov, this medical research is not actively recruiting any subjects at present; nevertheless, 24 other trials are currently enrolling participants. Initially posted in February of 2012 and last updated April 2015, it does not appear as if new patients will be sought for this study."
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