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

Recruiting now

Conditions studied: Carotid Artery Stenosis, Acute Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT05195658

Run by

John Paul II Hospital, Krakow

People needed

20

Starts

2022-01-30

Expected to finish

2027-12-31

Last updated by the study team

2022-02-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Consecutive patients with acute ischemic stroke with carotid artery bifurcation stenosis/occlusion as culprit lesion.
• Clinical picture of acute ischemic stroke, stroke-in-evolution, or crescendo TIAs.
• Patient eligible for endovascular stroke therapy according to AHA/ASA stroke management and accepted for emergent stroke intervention by the local NeuroVascular Team Committee according to local standard of practice.
• Signed informed consent form to participate in the study (obtained at the point of first feasibility; note that live-saving procedure track may be executed for performing intervention according to local regulations and routine practice in the center)
• Consent to (routinely performed in this group of patients) follow-up visits that may include imaging as per routine practice in the study center and as clinically indicated.

You may not qualify if…

• Known stroke cause other than the carotid bifurcation lesion
• Lack of effective endovascular route needed for intervention
• Any known contraindications to stroke endovascular management

Where it is running

• Department of Cardiac and Vascular Diseases, John Paul II Hospital — Krakow, Poland (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.