Acute Stroke of CArotid Artery Bifurcation Origin Treated With Use oF the MicronEt-covered CGUARD (SAFEGUARD-STROKE)
NCT ID: NCT05195658
Last Updated: 2022-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
20 participants
OBSERVATIONAL
2022-01-30
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
No contemporary clinical studies have been dedicated specifically to management acute stroke of carotid artery bifurcation origin. In contrast to cerebral artery occlusion, in which the treatment algorithm is well-established, in the stroke of carotid artery bifurcation origin neither the reperfusion window nor the optimal revascularization method are yet determined. This results in a low level of evidence regarding the choice of a particular treatment method - endovascular emergent mechanical revascularization or surgical. Carotid surgery in acute major stroke setting is particularly challenging. Also, the surgical treatment modality is unable to address the problem of acute embolus in the large intracerebral vessel(s) that co-exists in about one in every three patients with acute stroke of carotid bifurcation origin.
With regard to minimally-invasive endovascular treatment, one fundamental limitation of the carotid stents used so far to address the culprit lesion (single-layer, first-generation stents) has been their inability to adequately sequestrate (insulate) the atherothrombotic lesion, resulting in an increased risk of new cerebral embolism and enhancing the risk of stent acute occlusion. Circumstantial evidence suggests that the Micronet-covered stent (in particular in combination with 'proximal' cerebral protection and, whenever indicated and feasible, in combination with aspiration or stentriever thrombectomy) may increase both safety and efficacy of carotid revascularization in acute stroke of carotid bifurcation origin.
A novel dual-layered Micronet-covered stent system (CGuard) has been demonstrated to markedly reduce peri- (and eliminate post-) procedural cerebral embolism in elective carotid artery stenting (Level 1 evidence) but has not yet been systematically tested in the emergent setting. This prospective, single-center, clinical registry of patients with acute stroke of carotid artery bifurcation origin eligible for endovascular interventional management will evaluate the use of Micronet-covered Stent (CGuard) to seal the stroke culprit lesion and reconstruct the lumen of the artery supplying the brain. Proximal cerebral protection (by transient flow reversal using a balloon guide catheter such as the MoMa or FlowGate) is used whenever feasible. In addition, extra/intra-cranial thrombus retrieval will be performed as clinically indicated, using either the aspiration technique and/or a stentriever.
Eligibility for study treatment is based on the decision (recommendation) of a multidisciplinary NeuroVascular Team Committee, consisting of a cardioangiologist certified in stroke mechanical thrombectomy or an interventional (neuro)radiologist, stroke neurologist and anesthesiologist. Use of pharmacologic agents and intended devices is according to international guidelines and instructions for use.
The study involves evaluation of clinical and cerebrovascular imaging data (presentation, outcome) in consecutive patients with acute stroke of carotid artery bifurcation origin, presenting in the time-window and/or cerebral tissue window (salvageable cerebral tissue, small cerebral infarct core/large penumbra) allowing guideline-indicated reperfusion by interventional management. Cerebral and vascular non-invasive imaging will involve computed tomography and/or magnetic resonance imaging modalities as clinically indicated.
The study is a registry of consecutive patients with the study condition, treated using the device of interest. This is an open-label study, without randomization - a single arm, single-center study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Thrombectomy and Stenting under neuroprotection
Endovascular 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Thrombectomy and Stenting under neuroprotection
Endovascular 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Lack of effective endovascular route needed for intervention
* Any known contraindications to stroke endovascular management
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
John Paul II Hospital, Krakow
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Piotr Musialek, MD, DPhil
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiac and Vascular Diseases, John Paul II Hospital in Krakow
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Cardiac and Vascular Diseases, John Paul II Hospital
Krakow, , Poland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Piotr Musialek, MD, DPhil
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Tekieli L, Afanasjev A, Mazgaj M, Borodetsky V, Sievert K, Ruzsa Z, Knapik M, Sirvinskas A, Mazurek A, Dzierwa K, Sanczuk T, Mosenko V, Urbanczyk-Zawadzka M, Trystula M, Paluszek P, Wiewiorka L, Stefaniak J, Pieniazek P, Slautaite I, Kwiatkowski T, Mackevicius A, Teitcher M, Sievert H, Grunwald IQ, Musialek P. A multi-center study of the MicroNET-covered stent in consecutive patients with acute carotid-related stroke: SAFEGUARD-STROKE. Postepy Kardiol Interwencyjnej. 2024 Jun;20(2):172-193. doi: 10.5114/aic.2024.140963. Epub 2024 Jun 30.
Tekieli L, Dzierwa K, Grunwald IQ, Mazurek A, Urbanczyk-Zawadzka M, Wiewiorka L, Banys RP, Dabrowski W, Podlasek A, Weglarz E, Stefaniak J, Nizankowski RT, Musialek P. Outcomes in acute carotid-related stroke eligible for mechanical reperfusion: SAFEGUARD-STROKE Registry. J Cardiovasc Surg (Torino). 2024 Jun;65(3):231-248. doi: 10.23736/S0021-9509.24.13093-5.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SAFEGUARD-STROKE
Identifier Type: -
Identifier Source: org_study_id