OPTIMAl Endovascular Exclusion of Consecutive Patient High-risk Carotid Plaque Using the MicroNet Covered Stent
- Conditions
- Carotid Artery Diseases
- Interventions
- Diagnostic Test: Intravascular Utrasound (IVUS) of Carotid Artery after implantation of CGuard stent
- Registration Number
- NCT04234854
- Lead Sponsor
- John Paul II Hospital, Krakow
- Brief Summary
Prospective, multicentric, multispecialty, international, open-label, single arm study using per-protocol intravascular ultrasound \[IVUS, 20MHz electronic phase-array transducer\] to document the procedure result of an effective plaque exclusion from the vessel lumen.
- Detailed Description
Investigator initiated, academic, single arm, open-label, non-randomized, prospective, multicenter, multispecialty trial of CGuard™ use in all-comer population of consecutive patients with carotid stenosis related cerebral symptoms (TIA, stroke, retinal TIA, retinal stroke) or signs of ipsilateral brain injury on MRI or CT imaging.
The main objective of this observational study is to evaluate an incidence of residual plaque prolapse after carotid stenting using the study device.
Study Rationale In conventional carotid stents, plaque prolapse (PP) on intravascular imaging had been determined to be strongly associated with new post-procedural diffusion-weighted magnetic resonance lesions on cerebral imaging and with increased ischaemic stroke incidence. A significant increase in PP susceptibility was observed with unstable carotid plaque, pointing to the limitations of conventional CAS in unstable carotid plaques, such as symptomatic and increased-spontaneous-symptoms-risk lesions.
This is reflected in current guidelines that provide a higher recommendation class to surgical management (CEA) rather than CAS for symptomatic lesions.
Circumstantial evidence indicates that the novel carotid stent covered with MicroNET (CGuard EPS) may be an optimal device for effective carotid plaque sequestration (that may be particularly relevant in high-risk plaques) - but no systematic study has been performed thus far.
Because of the increasing evidence that not only clinical symptoms (that may be related to for instance the affection of dominant vs. non-dominant haemisphere) but also signs of ipisilateral cerebral infarct/s are a hallmark of high-risk plaque and are associated with adverse prognosis, and because that neurology increasingly uses the term "symptomatic" to refer to carotid stenosis associated with clinically silent ipisilateral cerebral infarct/s, the present study will enroll both patients with clinical symptoms of cerebral ischaemia in relation to carotid stenosis and those with (clinically silent) signs of ipsilateral injury such as ischemic focus/foci on CT or MRI/DW-MRI).
As previously demonstrated, clinically significant/relevant PP is that depicted by IVUS (with angiography, on the one hand, being not sensitive enough and OCT, on the other, being possibly too sensitive).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- All consecutive patients with clinically symptomatic carotid stenosis , or carotid stenosis associated with ipisilateral cerebral ischemic infarct/s on CT or MRI/DWI imaging, referred and accepted by the study center for CAS as per local standard referral pathways and study center routine.
- Patient informed consent to participate.
- Patient accepts follow-up scheme and consents to follow-up visits.
- Lack of indication to carotid revascularization as per current ESC/ESVS Guidelines, or any clinical or angiographic or other contraindication to CAS (such as renal failure defined as creatinine level > 2.5 mg/dL or eGFR <20 ml/kg min, or incompatibility with DAPT).
- Surgery within the preceding 30 days or planned surgery within 30 days after CAS.
- Life expectancy <1 year (eg. neoplastic disease).
- MI within 72h prior to CAS.
- Known coagulopathy.
- History of cerebral stroke with documented/known cause other than carotid disease.
- Atrial fibrillation or flutter.
- Any known cause for potential cerebral embolization different than carotid stenosis.
- History of intracranial bleeding.
- Any contraindications to as per IFU study device implantation.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Carotid Artery Stenting Intravascular Utrasound (IVUS) of Carotid Artery after implantation of CGuard stent Consecutive patients older than 18 yrs with symptomatic carotid artery stenosis qualified for endovascular revascularization.
- Primary Outcome Measures
Name Time Method Freedom from plaque prolapse During index procedure Freedom from plaque prolapse defined as observation of plaque inside the stent lumen after completion of the CAS procedure by IVUS assessment (Kotsugi 2017).
- Secondary Outcome Measures
Name Time Method IVUS interrogation success During index procedure IVUS interrogation with an effective IVUS probe removal in absence of any clinical complications
Ipsilateral stroke between 31 days and 12 months after the procedure Between 31 days and 12 months after the procedure Ipsilateral stroke between 31 days and 12 months after the procedure
Procedural success During index procedure stent delivery and implantation in absence of an intra-procedural clinical major adverse event, with no more than 30% residual diameter stenosis by on-site QCA, and successful withdrawal of the stent delivery and neuroprotection system
Periprocedural MACCE Until discharge or up to 24 hours Death, stroke, myocardial infarction until discharge or up to 24 hours
30 days MACCE 30 days Death, stroke, myocardial infarction until 30 days
Endovascular lumen reconstruction During index procedure Freedom from plaque prolapse plus minimal in-stent area \>50% ICA reference area
Any periprocedural complications Until discharge or up to 24 hours Any complications occurring until discharge or 24 hours whichever comes first
Duplex UltraSound (DUS) at 30 days 30 days Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) recorded by Duplex Doppler at 30±5 days after the procedure
Duplex UltraSound (DUS) at 12 months 12 months Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) recorded by Duplex Doppler at 12 months after the procedure
Trial Locations
- Locations (1)
Department of Cardiac and Vascular Diseases, The John Paul II Hospital
🇵🇱Kraków, Maloplska, Poland