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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Poland
Department of Cardiac and Vascular Diseases, John Paul II Hospital
RECRUITING
Krakow
Contact Information
Primary
Piotr Musialek, MD, DPhil
pmusialek@szpitaljp2.krakow.pl
+48126142287
Backup
Lukasz Tekieli, MD, PhD
luk.tekieli@gmail.com
+48126143501
Time Frame
Start Date: 2022-01-30
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 20
Treatments
Acute ischemic stroke with culprit lesion at the carotid bifurcation
Consecutive patients with acute ischemic stroke culprit lesion at the carotid bifurcation, accepted for emergent interventional management by the NeuroVascular Team Committee according to stroke management guidelines
Sponsors
Leads: John Paul II Hospital, Krakow

This content was sourced from clinicaltrials.gov