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Embolic Protection System
Roadsaver Stent + Nanoparasol for Carotid Stenosis
N/A
Waitlist Available
Led By Adnan Siddiqui, MD
Research Sponsored by Microvention-Terumo, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient is either symptomatic with carotid stenosis ≥50% as determined by angiography using NASCET methodology (amaurosis fugax ipsilateral to the carotid lesion; TIA or non-disabling stroke within 180 days of the procedure within the hemisphere supplied by the target vessel) or asymptomatic with carotid stenosis ≥80% as determined by angiography using NASCET methodology
Patient should have been diagnosed with carotid artery stenosis and be considered a high operative risk for carotid endarterectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 and 12 months
Awards & highlights
Study Summary
This trial is testing a new carotid stent system used with an embolic protection system. The safety and effectiveness of the system will be evaluated in patients at elevated risk for adverse events following carotid endarterectomy.
Who is the study for?
This trial is for adults aged 21-80 with carotid artery stenosis who are at high risk for surgery. Eligible participants must have a lesion that can be treated with the Roadsaver™ stent, meet certain anatomical or health-related criteria indicating higher surgical risks, and agree to follow-up requirements. Exclusions include those with other potential emboli sources, atrial fibrillation, severe blood disorders, uncontrolled diabetes, recent major strokes or heart attacks, and women who are pregnant.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of the Roadsaver™ Carotid Stent System used alongside the Nanoparasol® Embolic Protection System in patients with carotid artery stenosis. It's an observational study where all participants receive this combination treatment to see how well it works compared to traditional surgery.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks may include reactions to materials in the stent or protection system such as inflammation or allergic responses; complications from procedural errors like vessel damage; bleeding due to antiplatelet medication; and blockage of blood flow leading to stroke-like symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a narrowed carotid artery by at least 50% and symptoms, or it's narrowed by 80% without symptoms.
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I have been diagnosed with a narrowing of my carotid artery and am considered high risk for surgery.
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I have a single new or recurring blockage in my artery that can be treated with one stent.
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I have a high-risk condition related to my anatomy or health that qualifies me.
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My target lesion is located at the carotid bifurcation or proximal ICA.
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I am between 22 and 80 years old.
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My affected blood vessel is between 3.0 mm and 9.0 mm wide.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
All stroke, death, and MI
Ipsilateral stroke
Secondary outcome measures
In-stent restenosis
Major stroke
Minor stroke
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Single-arm, open labelExperimental Treatment2 Interventions
To evaluate the safety and effectiveness of MicroVention, Inc. Roadsaver™ Carotid Stent System used in conjunction with the Nanoparasol® embolic protection system for the treatment of carotid artery stenosis in patients with elevated risk for adverse events following carotid endarterectomy.
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Who is running the clinical trial?
Microvention-Terumo, Inc.Lead Sponsor
29 Previous Clinical Trials
5,986 Total Patients Enrolled
Adnan Siddiqui, MDPrincipal InvestigatorUniversity of Buffalo - Neurosurgery
1 Previous Clinical Trials
159 Total Patients Enrolled
Chris Metzger, MDPrincipal InvestigatorWellmont CVA Heart Institute
1 Previous Clinical Trials
315 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition that could cause blood clots, but I've been on blood thinners for at least two weeks.You are allergic to heparin or have had a serious reaction to it in the past.I currently have an infection.I have kidney failure or am on dialysis.I have diabetes that is not well-controlled.I have not had a brain bleed in the last 3 months.You have a history of drug or alcohol dependency that has not been resolved.I have a significant narrowing in the artery opposite to the one being studied.I can follow the study rules and be reached by phone.I have a disability that affects my daily activities, not caused by a stroke.I cannot take standard medications, including those for blood thinning.I have been diagnosed with a narrowing of my carotid artery and am considered high risk for surgery.I have a single new or recurring blockage in my artery that can be treated with one stent.I have a narrowed carotid artery by at least 50% and symptoms, or it's narrowed by 80% without symptoms.I have a high-risk condition related to my anatomy or health that qualifies me.You have had a serious stroke on one side of your body.My target lesion is located at the carotid bifurcation or proximal ICA.Your platelet count is less than 100,000 per microliter.I have had or plan to have a major surgery within 30 days of the main treatment.I have had a stroke in the last 30 days that has significantly affected my abilities.I am between 22 and 80 years old.My affected blood vessel is between 3.0 mm and 9.0 mm wide.I have severe kidney, liver issues, very high blood pressure, or am extremely overweight.I had a heart attack within the last 2 months.I have atrial fibrillation.You are expected to live for less than one year.I do not have brain conditions that would affect my study participation.I have a bleeding disorder or am at high risk for blood clots, or I refuse blood transfusions.
Research Study Groups:
This trial has the following groups:- Group 1: Single-arm, open label
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 it possible for me to become a participant in this experiment?
"This medical study is recruiting 295 participants aged between 21 and 80 who have a carotid artery stenosis. Among the necessary criteria, they must willingly provide informed consent; be considered at high risk for endarterectomy; possess target lesions that meet specific size requirements located at either the bifurcation or proximal ICA of their carotid artery; and display symptoms such as amaurosis fugax ipsilateral to the lesion or have had TIA/non-disabling stroke within 180 days of said procedure. Additionally, subjects with symptomatic stenosis ≥50% by NASCET methodology are eligible if"
Answered by AI
How many healthcare facilities are currently implementing this trial?
"This trail is being conducted at 40 different sites, with three main locations: Kaiser Permanente - Los Angeles in California, University Hospital in Ohio, and Overlook Medical Center in New jersey."
Answered by AI
Is this clinical research still open to new participants?
"According to clinicaltrials.gov, this trial is not presently enrolling patients, despite having been posted on the 21st of April 2016 and updated most recently on March 8th 2022. Fortunately, there are 227 other studies actively recruiting individuals at present."
Answered by AI
Is this trial recruiting geriatric patients?
"As per the trial's eligibility criteria, applicants must be between 21 and 80 years old in order to join this medical research."
Answered by AI
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