A Multicenter, Single-arm, Pivotal Study to Evaluate the Safety and Efficacy of the SwitchGuard™ Neuroprotection System (NPS) for Providing Cerebral Embolic Protection During Carotid Artery Stenting Via the Transcarotid Artery Revascularization (TCAR) Approach When Used in Conjunction With the CGuard™ Prime 80 Carotid Stent System
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- InspireMD
- 入组人数
- 103
- 主要终点
- Composite primary endpoint
概览
简要总结
This is a prospective, multi-center, single-arm, pivotal study. The objective of this study is to evaluate the safety and efficacy of the SwitchGuard NPS in providing cerebral embolic protection during Transcarotid Artery Revascularization procedures using the CGuard Prime Carotid Stent System 80 in the treatment of carotid artery stenosis in patients at high risk for complications from CEA.
详细描述
This study is a prospective, multi-center, single arm pivotal study. The study shall not be blinded prior to, during or following the procedure. Patients undergoing transcarotid artery revascularization will be screened against the study inclusion/exclusion criteria. If the patient meets study eligibility requirements, they shall be invited to participate, provided informed consent and shall subsequently be assigned a study ID number.
Enrollment will be 103 pivotal patients. A maximum of 20% of patients will be enrolled at any single site. The total enrollment accounts for an estimate that up to 2 patients will exit the study prior to the 30-day primary endpoint assessment.
An additional roll-in cohort of up to 2 patients per primary physician operator at each study site may also be accrued (maximum of 50 roll-in patients total, assuming one primary physician operator per site).
This study does not duplicate any current knowledge existing today on use of the SwitchGuard NPS when used in conjunction with the CGuard Prime™ 80cm in the United States.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 82 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.
- •Patient is diagnosed with carotid artery disease treatable with a Carotid Artery Stent via a Transcarotid Artery Revascularization approach and is either symptomatic or asymptomatic, defined as:
- •Symptomatic carotid stenosis ≥ 50%. Symptomatic is defined as amaurosis fugax, transient ischemia attack (TIA) or stroke within the last 6 months ipsilateral to the side of the stenosis OR asymptomatic carotid stenosis ≥ 80%
- •High Risk condition for CEA: at least one, as shown below:
- •Comorbid conditions:
- •Age ≥ 70 (maximum 82 years) CCS angina class 3-4 or unstable angina Congestive Heart Failure (CHF) NYHA class III-IV Left ventricular ejection fraction (LVEF) ≤ 35% MI ≥ 72 hours and \< 6 weeks pre-procedure Multi-vessel CAD (≥ 2 vessels \>70% stenosis) and history of angina Chronic Obstructive Pulmonary Disease (COPD) with FEV1\<50 Permanent contralateral cranial nerve injury/paralysis Restenosis from previous carotid endarterectomy (CEA) Planned coronary artery bypass grafting (CABG) or valve replacement surgery between 31-60 days after CAS Abdominal aortic aneurysm surgical repair or Endovascular repair is planned between 31 to 60 days after CAS
- •Anatomic conditions:
- •Occlusion of the contralateral CCA or ICA Prior radiation treatment to the neck or a radical neck dissection Severe bilateral ICA stenosis requiring treatment Target lesion at or above the level of the jaw (C2) or below the clavicle Severe tandem lesions Inability to extend the neck due to cervical disorders Laryngeal palsy or laryngectomy Prior head and neck surgery in the region of the carotid artery Tracheostomy or tracheostoma Spinal immobility of the neck
排除标准
- •Patient had or will have an interventional procedure or surgery of the carotid, coronary or peripheral arteries within 30 days before or after the index carotid procedure
- •Patient had or will have open heart surgery or valvular intervention (percutaneous or surgical), or any major operation, within 30 days before or after the index carotid procedure
- •Vascular anatomy that would preclude safe sheath insertion or deliverability of stent
- •Previously placed stent in the ipsilateral ICA or CCA
- •Total occlusion or presence of a "string sign" of the ipsilateral ICA or CCA
- •Presence of a filling defect of the target lesion
- •Tandem lesions, which cannot be covered by a single CGuard Prime stent
- •Stenosis of the innominate artery or proximal CCA requiring revascularization
- •Open neck stoma
- •History of bleeding diatheses or coagulopathy
结局指标
主要结局
Composite primary endpoint
时间窗: 30 days
Incidence of the composite primary endpoint comprised of Death (all-cause mortality), all Stroke, or Myocardial Infarction (DSMI) through 30-days post-index procedure, based on Clinical Events Committee (CEC) adjudication.
次要结局
- Rate of all death within 30 days of the procedure(30 days)
- Rate of cardiac death within 30 days of the index procedure(30 days)
- Rate of neurological death within 30 days of the index procedure(30 days)
- Rate of all strokes within 30 days of the procedure(30 days)
- Rate of major stroke within 30 days of the procedure(30 days)
- Rate of minor stroke within 30 days of the procedure(30 days)
- Rate of ipsilateral stroke within 30 days of the procedure(30 days)
- Rate of MI within 30 days of the procedure(30 days)
- Composite of death or stroke rate within 30 days of the procedure(30 days)
- Rate of cranial nerve injury within 30 days of the procedure(30 days)
- Access site complications (arterial/venous)(At procedure)
- All device-related serious adverse events within 30 days of the procedure(30 days)
- Acute success for the SwitchGuard NPS(At procedure)
- Acute success for CGuard Prime 80cm Delivery System and Stent(At procedure)
- Technical Success for the CGuard Prime 80cm Delivery System and Stent(At procedure)
- Procedural success(30 days)
- Treatment Success for the CGuard Prime 80cm Delivery System and Stent(30 days)