Tests a covered stent and clot removal for acute stroke from neck artery blockage
Studies stent and clot removal in adults with sudden stroke from neck artery blockage.
Plain-language title generated from the registry record
Registry title: Acute Stroke of CArotid Artery Bifurcation Origin Treated With Use oF the MicronEt-covered CGUARD (SAFEGUARD-STROKE)
Key facts
- Where
- Krakow, PolandSee the site
Where in Poland
- Department of Cardiac and Vascular Diseases, John Paul II HospitalKrakow, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- John Paul II Hospital, Krakow
- Trial code
- NCT05195658
- Record updated
- 28 February 2022
- Original description
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.Read full original descriptionShow less
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
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.
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; Any known contraindications to stroke endovascular management; Lack of effective endovascular route needed for intervention.