Treatment of acute stroke caused by carotid artery issues using a specialized stent
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
John Paul II Hospital, Krakow · NCT05195658
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 |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | John Paul II Hospital, Krakow (other) |
| Locations | 1 site (Krakow) |
| Trial ID | NCT05195658 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with acute ischemic stroke caused by carotid artery bifurcation stenosis or occlusion who are eligible for endovascular therapy.
Not a fit: Patients with strokes caused by factors other than carotid bifurcation lesions will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Krakow
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Carotid Artery Stenosis, Acute Ischemic Stroke, Carotid Stenosis, Anesthesia, Imaging, Interventional Management, Thrombectomy