Clinical trial NCT05195658: Acute Stroke of CArotid Artery Bifurcation Origin Treated With Use oF the MicronEt-covered CGUARD (SAFEGUARD-STROKE)
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carotid Artery Stenosis
Acute Ischemic Stroke
Keywords: Carotid Stenosis
Acute Ischemic Stroke
Anesthesia
Imaging
Interventional Management
Thrombectomy
Lead sponsor: John Paul II Hospital, Krakow
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* Known stroke cause other than the carotid bifurcation lesion
* Lack of effective endovascular route needed for intervention
* Any known contraindications to stroke endovascular management

Primary outcomes:
measure: Freedom from poor clinical status at 90 days
timeFrame: 90 days from index procedure
Secondary outcomes:
measure: Freedom from major clinical complications comprising MACNE (major adverse cardiovascular or neurologic event) at 30 days
timeFrame: At 30 days from index procedure
measure: Freedom from major clinical complications comprising MACNE at 90 days
timeFrame: At 90 days from index procedure
measure: Freedom from major clinical complications comprising MACNE at 12 months
timeFrame: At 12 months from index procedure
measure: Procedural success rate for carotid intervention
timeFrame: Periprocedural
measure: Technical success rate for carotid intervention
timeFrame: At procedure completion
measure: Clinical success rate for carotid intervention
timeFrame: 90 days after procedure
measure: Rate of successful cerebral recanalization
timeFrame: At procedure completion
measure: Freedom from embolism to the new territory during procedure
timeFrame: During index procedure
measure: Rate of peri-procedural cerebral complications
timeFrame: At procedure completion
measure: Rate of other major periprocedural complications
timeFrame: Up to 7 days post-procedure
measure: New ipsilateral stroke free survival up to 1 year
timeFrame: From procedure completion till 1 year post-procedure
measure: New ipsilateral stroke free survival up to 5 year
timeFrame: From procedure completion till 5 years post-procedure
measure: Carotid restenosis free survival up to 1 year
timeFrame: From procedure completion till 1 year post-procedure
measure: Carotid restenosis free survival up to 5 years
timeFrame: From procedure completion till 5 years post-procedure
measure: Rate of carotid reintervention
timeFrame: From procedure completion till 5 years post-procedure
measure: Feasibility of combined treatment
timeFrame: At the procedure completion
measure: NIHSS score change
timeFrame: At 90 days post procedure
measure: Freedom from stent thrombosis at 30 days
timeFrame: At 30 days post procedure
measure: Freedom from stent thrombosis at 90 days
timeFrame: At 90 days post procedure
measure: Freedom from stent thrombosis or in-stent restenosis up to 1 year
timeFrame: At 1 year after procedure
measure: Stent thrombosis or in-stent restenosis up to 5 years
timeFrame: At 5 years after procedure
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Department of Cardiac and Vascular Diseases, John Paul II Hospital
Study officials:
affiliation: Department of Cardiac and Vascular Diseases, John Paul II Hospital in Krakow
name: Piotr Musialek, MD, DPhil
role: PRINCIPAL_INVESTIGATOR
References: