CompletedNot Applicable

Pilot Study of Autoarterial Remodeling of Bifurcation of the Common Carotid Artery

Russia200 participantsStarted 2016-12

Plain-language summary

Comparison of two methods for revascularization of the bifurcation of common carotid artery: carotid endarterectomy with longitudinal incision carotid endarterectomy patch angioplasty compared with new technique of carotid endarterectomy with autoarterial remodeling of bifurcation of the common carotid artery

Who can participate

Age range

40 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: * stenotic lesions of the extracranial part of carotid arteries requiring surgical treatment according to national treatment guidelines (asymptomatic ICA stenosis more than 70% symptomatic ICA stenosis more than 65%) * the length of the atherosclerotic plaques in the ICA than 1 cm * personally signed Informed consent for participation in the study Exclusion Criteria: * Chronic heart failure III-IV functional class NYHA classification * Chronic decompensated "lung" heart * Decompensated diseases of endocrine organs (diabetes glycemia more than 10 mmol/l) * Severe hepatic or renal insufficiency (bilirubin \>80 mmol/l, creatinine \>200 mmol/l) * Polyvalent drug Allergy; * Malignant tumor in the terminal stage with life expectancy of up to 6 months; * Acute disruption of cerebral blood flow * Extensive occlusion of the internal carotid artery. * Exacerbation of systemic diseases. * Pregnancy and lactation. * The refusal of a patient to sign informed consent for participation in the study

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.

What they're measuring

Stroke or TIA

Timeframe: throughout 1 year

Trial details

NCT IDNCT03027752

SponsorMeshalkin Research Institute of Pathology of Circulation

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2018-09-30

View on ClinicalTrials.gov More Stenosis, Internal Carotid Artery trials