Status:
RECRUITING
Acute Stroke of CArotid Artery Bifurcation Origin Treated With Use oF the MicronEt-covered CGUARD (SAFEGUARD-STROKE)
Lead Sponsor:
John Paul II Hospital, Krakow
Conditions:
Carotid Artery Stenosis
Acute Ischemic Stroke
Eligibility:
All Genders
18+ years
Brief 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 c...
Detailed Description
Acute stroke of carotid artery bifurcation origin presents a major treatment challenge. With the large volume of affected brain tissue, this stroke type -if left untreated- has an extremely unfavorabl...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Known stroke cause other than the carotid bifurcation lesion
- Lack of effective endovascular route needed for intervention
- Any known contraindications to stroke endovascular management
Key Trial Info
Start Date :
January 30 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05195658
Start Date
January 30 2022
End Date
December 31 2027
Last Update
February 28 2022
Active Locations (1)
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1
Department of Cardiac and Vascular Diseases, John Paul II Hospital
Krakow, Poland, 31-202