An observational study in Carotid Artery Stenosis and Acute Ischemic Stroke, sponsored by John Paul II Hospital, Krakow. Recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-28.
Sponsored by John Paul II Hospital, Krakow · Observational
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.
Acute stroke of carotid artery bifurcation origin presents a major treatment challenge. With the large volume of affected brain tissue, this stroke type -if left untreated- has an extremely unfavorable prognosis. With a typical large thrombus load in the extracranial carotid artery, the efficacy of systemic intravenous thrombolysis - the mainstay of ischemic stroke treatment- is very poor (reported recanalization rates \<5%). With a high risk of complications (including cerebral embolism) and poor clinical outcomes, patients with acute stroke of carotid artery bifurcation origin (≈20-30% large-vessel occlusion strokes) are underrepresented in stroke mechanical reperfusion trials that have typically not included such patients.
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.
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.
Exclusion Criteria:
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
Device: 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.
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 procedure
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 procedure
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 procedure
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 procedure
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: Periprocedural
Technical success rate for carotid intervention
Number of procedures completed using the study device in relation to the number of attempted procedures
Time frame: At procedure completion
Clinical success rate for carotid intervention
Number of procedures completed with a good clinical outcome (mRS 0-2 at 90 days) in relation to the number of attempted procedures
Time frame: 90 days after procedure
Rate of successful cerebral recanalization
Rate of patients with index hemisphere optimal cerebral flow post-procedurally (modified TICI 2b or 3)
Time frame: At procedure completion
Freedom from embolism to the new territory during procedure
Freedom from embolism to the new territory at the post-procedural angiogram
Time frame: During index procedure
Rate of peri-procedural cerebral complications
Rate of patients with peri-procedural cerebral complications such as embolism to new territory or symptomatic intracranial haemorrhage (i.e. parenchymal haematoma on imaging with clinical deterioration).
Time frame: At procedure completion
Rate of other major periprocedural complications
Rate of patients with other major peri-procedural complications: acute renal failure, systemic infection, respiratory failure requiring prolonged ventilation (\>24 hours), vascular access site complication requiring surgery
Time frame: Up to 7 days post-procedure
New ipsilateral stroke free survival up to 1 year
Survival without any stroke up to 1 year follow up
Time frame: From procedure completion till 1 year post-procedure
New ipsilateral stroke free survival up to 5 year
Survival without any stroke up to 5 year follow up
Time frame: From procedure completion till 5 years post-procedure
Carotid restenosis free survival up to 1 year
Survival without carotid restenosis requiring treatment up to 1 year follow up
Time frame: From procedure completion till 1 year post-procedure
Carotid restenosis free survival up to 5 years
Survival without carotid restenosis requiring treatment up to 5 year follow up
Time frame: From procedure completion till 5 years post-procedure
Rate of carotid reintervention
Rate of patients with clinically indicated reintervention in the index carotid artery during follow up period
Time frame: From procedure completion till 5 years post-procedure
Feasibility of combined treatment
Number of patients actually treated with combined treatment (defined as the use of Micronet-covered stent and proximal cerebral protection) to the number of patients with attempted such treatment
Time frame: At the procedure completion
NIHSS score change
Change in National Institutes of Health Stroke Scale score between the point of presentation and 90 days.
Time frame: At 90 days post procedure
Freedom from stent thrombosis at 30 days
Freedom from clinical or ultrasound stent thrombosis detected within 30 days after procedure
Time frame: At 30 days post procedure
Freedom from stent thrombosis at 90 days
Freedom from clinical or ultrasound stent thrombosis detected within 90 days after procedure
Time frame: At 90 days post procedure
Freedom from stent thrombosis or in-stent restenosis up to 1 year
Freedom from clinical or ultrasound stent thrombosis or significant in-stent restenosis detected within 12 months after procedure
Time frame: At 1 year after procedure
Stent thrombosis or in-stent restenosis up to 5 years
Clinical or ultrasound stent thrombosis or significant in-stent restenosis detected within 5 years after procedure
Time frame: At 5 years after procedure
Plan to share: Undecided
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
John Paul II Hospital, Krakow