Treatment of acute stroke caused by carotid artery issues using a specialized stent
Official title: Acute Stroke of CArotid Artery Bifurcation Origin Treated With Use oF The MicronEt-covered CGUARD STent Under TRansient FlOw Reversal LinKed With Thrombus REtrieval: SAFEGUARD-STROKE Study
Run by John Paul II Hospital, Krakow · NCT05195658 · Data updated 2026-11-12
This study is testing a special stent treatment for people who have had a stroke caused by problems in their carotid artery to see if it helps them recover better.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | John Paul II Hospital, Krakow Academic / other |
| Locations | 1 site (Krakow) |
| Status | Recruiting |
| Started | January 30, 2022 |
| Main results expected | December 31, 2022 |
| Study ends | December 31, 2027 |
| Registry record updated | February 28, 2022 |
| Trial ID | NCT05195658 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with acute ischemic stroke caused by carotid artery bifurcation stenosis or occlusion who are eligible for endovascular therapy.
✕Probably not a fit
Patients with strokes caused by factors other than carotid bifurcation lesions will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on patients experiencing acute ischemic stroke due to carotid artery bifurcation stenosis or occlusion. It involves a single-center registry at John Paul II Hospital in Krakow, where patients undergo endovascular treatment with a Micronet-covered CGUARD stent, utilizing neuroprotection techniques such as transient flow reversal. The study aims to gather clinical and imaging data to evaluate the effectiveness of this intervention in a patient population that is often underrepresented in stroke treatment trials.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients suffering from acute strokes related to carotid artery issues.
How similar studies have gone: This study addresses a gap in existing research, as no contemporary studies have specifically focused on the management of acute strokes from carotid artery bifurcation origin.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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's running
-
Department of Cardiac and Vascular Diseases, John Paul II Hospital
Krakow, Poland Recruiting
Study contacts
- Principal investigator: Piotr Musialek, MD, DPhil — Department of Cardiac and Vascular Diseases, John Paul II Hospital in Krakow
- Study coordinator: Piotr Musialek, MD, DPhil
- Email: pmusialek@szpitaljp2.krakow.pl
- Phone: +48126142287
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.