CompletedNot Applicable

The SIBERIA Trial (Acculink™ Versus CGuard™)

Russia100 participantsStarted 2017-09-11

Plain-language summary

That the study will be carried out as it has the protocol instructions, respecting the applicable regulations for clinical investigations with medical devices and following the internationally accepted ethical standards

Who can participate

Age range

45 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

. Consecutive patients 45-80 years old accepted for CAS following neurological consultation and qualification for the procedure according to center's routine practice.
. More than 6-month life expectancy
. Suitable clinical conditions for performing DW-MRI
. Written Informed consent approved by the Ethics Committee
. Subject agrees to all required follow-up procedures and visits

Exclusion criteria

. Currently enrolled in another investigational device or drug study that has not completed the study or that clinically interferes with the current study endpoints
. Recent surgical procedure within 30-days before or planned surgery within 30-days after the stenting procedure
. Hepatic active disease (bilirubin\> 35 mmol / l) or renal insufficiency (serum creatinine \> 2.5 mg/dL or glomerular filtration rate \<60 ml / min)
. Recent evolving acute stroke within 30-days of study evaluation
. Myocardial infarction within 72 hours prior to carotid stenting procedure (CPK-MB \> 3 times normal)

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

determination of ischemic lesions

Timeframe: at 30-days

determination of ischemic lesions

Timeframe: at 48 hours

Trial details

NCT IDNCT03488199

SponsorMeshalkin Research Institute of Pathology of Circulation

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2021-02-11

View on ClinicalTrials.gov More Patients With Aterosclerotic Carotid Stenosis trials