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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study summary

Prospective, single-center, clinical registry of patients with acute stroke of carotid artery bifurcation origin undergoing endovascular treatment using the Micronet-covered CGUARD Stent to seal the culprit lesion under proximal cerebral protection (by transient flow reversal using balloon catheter such as the MoMa or FlowGate) with thrombus retrieval achieved through active aspiration ± stentriever use.

A study involving clinical and cerebrovascular imaging data evaluation in consecutive patients with acute stroke of carotid artery bifurcation origin, presenting in the time-window and/or cerebral tissue window allowing guideline-indicated reperfusion by interventional management.

A registry of consecutive patients with the study condition. An open-label study, without randomization - a single arm, single-center study in John Paul II Hospital in Krakow, Poland.

Eligibility

Primary outcome measure(s)

• Freedom from poor clinical status at 90 days — 90 days from index procedure
  Freedom from poor clinical status (expressed as modified Rankin score, mRS \>2) at 90 days

Trial sites (1)

More John Paul II Hospital, Krakow trials in Poland

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