A multi-center study of the MicroNET-covered stent in consecutive patients with acute carotid-related stroke: SAFEGUARD-STROKE.
Lukasz Tekieli, Andrej Afanasjev, Maciej Mazgaj...
https://pubmed.ncbi.nlm.nih.gov/39022700Actively Recruiting
Led by John Paul II Hospital, Krakow · Updated on 2022-02-28
20
Participants Needed
1
Research Sites
260 weeks
Total Duration
Researchers are evaluating the use of the Micronet-covered CGuard stent to treat patients with acute stroke caused by blockage at the carotid artery bifurcation. This type of stroke is challenging to treat and often has poor outcomes with standard intravenous clot-busting treatments. The study aims to assess this device in an urgent, real-world setting where current treatment options and timing for intervention are not well established. This is a single-center, open-label registry study including consecutive patients who qualify for endovascular management. The treatment involves placing the Micronet-covered stent to seal the clot-causing lesion while using proximal cerebral protection through transient flow reversal achieved by balloon catheters like MoMa or FlowGate. When needed, clot removal from the arteries supplying the brain is performed using aspiration devices or stentrievers. Patient management, including anesthesia choice and medications, follows established stroke guidelines and routine clinical practice at the study center. Participants will undergo clinical evaluations and brain and blood vessel imaging such as CT or MRI at presentation and during follow-up. The study will track safety and effectiveness outcomes including clinical status at 90 days, procedural success, stroke recurrence, and complications over up to 5 years. Follow-up visits may include imaging and assessments as per routine care. The total participation duration depends on each patient’s clinical course and follow-up schedule.
CONDITIONS
Acute Stroke of CArotid Artery Bifurcation Origin Treated With Use oF the MicronEt-covered CGUARD (SAFEGUARD-STROKE)
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with immediate post-procedural care
Participants undergo an endovascular procedure using the Micronet-covered CGuard stent under neuroprotection to treat the stroke lesion at the carotid artery bifurcation. This includes transient flow reversal with a balloon guide catheter and, if indicated, thrombus retrieval using aspiration or a stentriever. Management follows routine clinical practice and stroke guidelines.
1 procedural visit (in-person)
Duration - Up to 5 years post-procedure
Participants are monitored over time to assess clinical outcomes, complications, and stent performance according to standard follow-up protocols.
Follow-up visits at 30 days, 90 days, 1 year, and annually up to 5 years
Total: 1 location
1
Department of Cardiac and Vascular Diseases, John Paul II Hospital
Krakow, Poland, 31-202
Actively Recruiting
P
Piotr Musialek, MD, DPhil
L
Lukasz Tekieli, MD, PhD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Lukasz Tekieli, Andrej Afanasjev, Maciej Mazgaj...
https://pubmed.ncbi.nlm.nih.gov/39022700Lukasz Tekieli, Karolina Dzierwa, Iris Q Grunwald...
https://pubmed.ncbi.nlm.nih.gov/39007556