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Compares treatment options for Patients With Aterosclerotic Carotid Stenosis
Official title Carotid Revascularization With MicroNet Covered Stent Comparing Early Neurological Outcomes With Distal Versus Proximal EPS
ClinicalTrials.gov ID: NCT05257161
What this study is testing
- What it's testing
- The SIBERIA study demonstrated a clear advantage of CGuard stent implantation over the existing classical stent when using a distal anti-embolic device. At the same time, there is no Level 1 evidence for a difference between the proximal and distal anti-embolic device for the CGuard stent.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 80
You may be able to join if
- Consecutive patients 45-80 years old accepted for CAS following neurological consultation and qualification for the procedure according to center's...
- 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
You likely can't join if
- Currently enrolled in another investigational device or drug study that has not completed the study or that clinically interferes with the current...
- 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)
- Female patients of childbearing potential or known to be pregnant
See the full eligibility 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
- 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)
- Female patients of childbearing potential or known to be pregnant
- Any known factor for potential stroke other than carotid stenosis, such as atrial fibrillation or atrial flutter (paroxysmal, permanent or persistent) or thrombophilia
- Patient on VKA or new oral anticoagulants
The study team makes the final eligibility decision.
Where it's taking place
- Novosibirsk, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Novosibirsk, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.