Protection Against Emboli During Carotid Artery Stenting Using the Neuroguard IEP System (NCT04201132) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Protection Against Emboli During Carotid Artery Stenting Using the Neuroguard IEP System
United States, Bulgaria, Germany305 participantsStarted 2020-06-12
Plain-language summary
A prospective, multicenter single-arm, open label study to evaluate the safety and effectiveness of the Neuroguard IEP System for the treatment of carotid artery stenosis in subjects at elevated risk for adverse events following carotid endarterectomy (CEA).
Who can participate
Age range
20 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and non-pregnant, non-breastfeeding female subjects whose age is ≥ 20 years and ≤ 80.
. Patient is willing and capable of complying with all study protocol requirements, including the specified follow-up visits and can be contacted by telephone.
. Patient or his/her authorized legal representative must sign a written informed consent form that has been approved by the local governing Institutional Review Board (IRB)/ Ethics Committee (EC) of the respective clinical site.
. Patient is diagnosed with carotid artery stenosis treatable with carotid artery stenting and is considered a high operative risk for CEA.
. Patient is diagnosed with either:
. Symptomatic carotid stenosis ≥ 50% as determined by angiography using NASCET methodology. Symptomatic is defined as ipsilateral transient monocular blindness: amaurosis fugax; ipsilateral carotid transient ischemic attack (TIA), with neurologic symptoms persisting less than 24 hours; or ipsilateral non-disabling stroke within 180 days of the procedure; or
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Asymptomatic carotid stenosis ≥ 80% as determined by angiography using NASCET methodology.
. Patient has a modified Rankin Scale score of ≤ 2 at the time of informed consent.
Exclusion criteria
. Life expectancy of less than one year, cancer with metastatic spread, undergoing active chemotherapy treatment, or currently requiring an organ transplantation.
. An evolving acute stroke.
. Anticipated or potential sources of emboli including left ventricular aneurysm, severe cardiomyopathy, aortic or mitral mechanical heart valve, severe calcific aortic stenosis (valve area \< 1.0 cm2), endocarditis, moderate to severe mitral stenosis, known previously symptomatic PFO, left atrial thrombus, any intracardiac mass or DVT or PE treated within the past 12 months.
. History of paroxysmal atrial flutter or atrial fibrillation requiring chronic anticoagulation
. History of chronic atrial flutter or atrial fibrillation.
. Anticoagulation with Phenprocoumon (Marcumar®), warfarin, or a direct thrombin inhibitor, or anti-Xa agents within 14 days of the index procedure.
. Acute febrile illness (temperature \> 100.4F or 38C) or active infection.
. Subjects with presumptive or confirmed SARS-CoV-2/COVID-19 infection.