OPTIMAl Endovascular Exclusion of Consecutive Patient High-risk Carotid Plaque Using the MicroNet… (NCT04234854) | Clinical Trial Compass
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OPTIMAl Endovascular Exclusion of Consecutive Patient High-risk Carotid Plaque Using the MicroNet Covered Stent
Poland200 participantsStarted 2020-01-31
Plain-language summary
Prospective, multicentric, multispecialty, international, open-label, single arm study using per-protocol intravascular ultrasound \[IVUS, 20MHz electronic phase-array transducer\] to document the procedure result of an effective plaque exclusion from the vessel lumen.
Who can participate
Age range
18 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:
* All consecutive patients with clinically symptomatic carotid stenosis , or carotid stenosis associated with ipisilateral cerebral ischemic infarct/s on CT or MRI/DWI imaging, referred and accepted by the study center for CAS as per local standard referral pathways and study center routine.
* Patient informed consent to participate.
* Patient accepts follow-up scheme and consents to follow-up visits.
Exclusion Criteria:
* Lack of indication to carotid revascularization as per current ESC/ESVS Guidelines, or any clinical or angiographic or other contraindication to CAS (such as renal failure defined as creatinine level \> 2.5 mg/dL or eGFR \<20 ml/kg min, or incompatibility with DAPT).
* Surgery within the preceding 30 days or planned surgery within 30 days after CAS.
* Life expectancy \<1 year (eg. neoplastic disease).
* MI within 72h prior to CAS.
* Known coagulopathy.
* History of cerebral stroke with documented/known cause other than carotid disease.
* Atrial fibrillation or flutter.
* Any known cause for potential cerebral embolization different than carotid stenosis.
* History of intracranial bleeding.
* Any contraindications to as per IFU study device implantation.
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.