Acute Stroke of CArotid Artery Bifurcation Origin Treated With Use oF the MicronEt-covered CGUARD (SAFEGUARD-STROKE)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJohn Paul II Hospital, Krakow
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Known stroke cause other than the carotid bifurcation lesion
Lack of effective endovascular route needed for intervention
Any known contraindications to stroke endovascular management
Trial population
All-comers clinical registry of consecutive patients with acute ischemic stroke culprit lesion at the carotid bifurcation, cleared for emergent interventional management by the NeuroVascular Team Committee according to stroke management guidelines.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Thrombectomy and Stenting under neuroprotection
DeviceEndovascular management of the stroke culprit lesion using the Micronet-covered CGuard stent under neuroprotection. Transient flow achieved using a balloon guide catheter (e.g. MoMa or FlowGate) with additional active aspiration/s at key procedural steps. If indicated, targeted (extra- and/or intracranial) thrombus retrieval using either a thrombus aspiration device and/or a stentriever. Use of pharmaco-sedation versus general anesthesia is as indicated clinically and is according to the anesthesiologist and operator decision - according to routine practice in the center. Patient pre-procedural (including imaging and other diagnostic work-up), procedural, and post-procedural (including blood pressure tight control) management, including pharmacotherapy, are according to the AHA/ASA stroke management guidelines and the devices IFUs. Overall study patient management and intervention is according to routine clinical practice in the study center.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Acute ischemic stroke with culprit lesion at the carotid bifurcation1 intervention
Trial outcomes
Primary outcomes
1
Freedom from poor clinical status at 90 days
Freedom from poor clinical status (expressed as modified Rankin score, mRS \>2) at 90 days
Time frame
90 days from index procedureSecondary outcomes
1
Freedom from major clinical complications comprising MACNE (major adverse cardiovascular or neurologic event) at 30 days
Freedom from any death, any new stroke (ischemic or hemorrhagic, including hemorrhagic transformation of index stroke), and myocardial infarction at 30-day follow-up
Time frame
At 30 days from index procedure2
Freedom from major clinical complications comprising MACNE at 90 days
Freedom from any death, any new stroke (ischemic or hemorrhagic, including hemorrhagic transformation of index stroke), and myocardial infarction at 90-day follow-up
Time frame
At 90 days from index procedure3
Freedom from major clinical complications comprising MACNE at 12 months
Freedom from any death, any new stroke (ischemic or hemorrhagic, including hemorrhagic transformation of index stroke), and myocardial infarction at 12-months follow-up
Time frame
At 12 months from index procedure4
Procedural success rate for carotid intervention
Rate of patients with success of endovascular treatment of the culprit carotid lesion i.e. procedural success (stent delivery and implantation, withdrawal of stent delivery system, residual stenosis ≤30% of vessel lumen diameter, procedure without complications)
Time frame
PeriproceduralSponsors and contacts
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Source ClinicalTrials.gov