OPTIMAl Endovascular Exclusion of High-risk Carotid Plaque Using the CGuard™ Stent in Patients With Symptoms or Signs of Carotid Stenosis-related Brain Injury: IVUS Controlled Investigator Initiated Multcentric Multi-specialty Study
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Freedom from plaque prolapse
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Freedom from plaque prolapse
时间窗: 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).
次要结局
- IVUS interrogation success(During index procedure)
- Ipsilateral stroke between 31 days and 12 months after the procedure(Between 31 days and 12 months after the procedure)
- Procedural success(During index procedure)
- Periprocedural MACCE(Until discharge or up to 24 hours)
- 30 days MACCE(30 days)
- Endovascular lumen reconstruction(During index procedure)
- Any periprocedural complications(Until discharge or up to 24 hours)
- Duplex UltraSound (DUS) at 30 days(30 days)
- Duplex UltraSound (DUS) at 12 months(12 months)