Actively Recruiting
Acute Stroke of CArotid Artery Bifurcation Origin Treated With Use oF the MicronEt-covered CGUARD (SAFEGUARD-STROKE)
Led by John Paul II Hospital, Krakow · Updated on 2022-02-28
20
Participants Needed
1
Research Sites
308 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Acute Stroke of CArotid Artery Bifurcation Origin Treated With Use oF the MicronEt-covered CGUARD (SAFEGUARD-STROKE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Consecutive patients with acute ischemic stroke with carotid artery bifurcation stenosis or occlusion as the cause
- Clinical signs of acute ischemic stroke, stroke-in-evolution, or repeated transient ischemic attacks
- Eligibility for endovascular stroke therapy based on AHA/ASA guidelines and approval by local NeuroVascular Team
- Signed informed consent to participate in the study
- Agreement to follow-up visits including imaging as per routine clinical practice
You will not qualify if you...
- Known stroke cause other than carotid bifurcation lesion
- Lack of an effective endovascular route for intervention
- Any known contraindications to endovascular stroke treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Cardiac and Vascular Diseases, John Paul II Hospital
Krakow, Poland, 31-202
Actively Recruiting
Research Team
P
Piotr Musialek, MD, DPhil
CONTACT
L
Lukasz Tekieli, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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