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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Page 1 of 1 (1 locations)

1

Department of Cardiac and Vascular Diseases, John Paul II Hospital

Krakow, Poland, 31-202