Acute Stroke of CArotid Artery Bifurcation Origin Treated With Use oF the MicronEt-covered CGUARD (SAFEGUARD-STROKE)

RecruitingOBSERVATIONAL
Enrollment

20

Participants

Timeline

Start Date

January 30, 2022

Primary Completion Date

December 31, 2022

Study Completion Date

December 31, 2027

Conditions
Carotid Artery StenosisAcute Ischemic Stroke
Interventions
DEVICE

Thrombectomy and Stenting under neuroprotection

"Endovascular management of the stroke culprit lesion using the Micronet-covered CGuard stent under neuroprotection.~Transient flow achieved using a balloon guide catheter (e.g. MoMa or FlowGate) with additional active aspiration/s at key procedural steps. If indicated, targeted (extra- and/or intracranial) thrombus retrieval using either a thrombus aspiration device and/or a stentriever.~Use of pharmaco-sedation versus general anesthesia is as indicated clinically and is according to the anesthesiologist and operator decision - according to routine practice in the center.~Patient pre-procedural (including imaging and other diagnostic work-up), procedural, and post-procedural (including blood pressure tight control) management, including pharmacotherapy, are according to the AHA/ASA stroke management guidelines and the devices IFUs. Overall study patient management and intervention is according to routine clinical practice in the study center."

Trial Locations (1)

31-202

RECRUITING

Department of Cardiac and Vascular Diseases, John Paul II Hospital, Krakow

All Listed Sponsors
lead

John Paul II Hospital, Krakow

OTHER