NCT07458243尚未招募不适用
A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- • Procedural success
研究概览
简要总结
The study is a prospective, non-randomized, single-arm, multi-center registry to confirm the safe delivery of the Carotid WALLSTENT Endoprosthesis when used with the ENROUTE® Transcarotid Neuroprotection System in the Chinese population
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
- •1. Patients must meet one of the following criteria regarding neurological symptom status and degree of stenosis: Symptomatic: Stenosis must be >50% as determined by an angiogram (CTA/MRA or catheter angiogram prior to the index procedure) and the patient has a history of stroke (minor or non-disabling; NIHSS ≤4 or mRS ≤2), TIA and/or amaurosis fugax within 180 days of the procedure ipsilateral to the carotid artery to be stented.
- •OR Asymptomatic: Stenosis must be ≥70% as determined by angiogram (CTA/MRA or catheter angiogram prior to the index procedure) without any neurological symptoms within the prior 180 days.
- •2. Target vessel must meet all requirements for ENROUTE Transcarotid Neuroprotection System and Carotid WALLSTENT Endoprosthesis (refer to IFU for requirements).
- •3. Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA).
- •4. Patient is ≥18 years of age.
- •Patient understands the nature of the procedure and has provided a signed informed consent using a form that has been reviewed and approved by the Institutional Review Board/Ethics Committee of the respective clinical site prior to the procedure. This will be obtained prior to participation in the study.
- •6. Patient is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
排除标准
- •1. Patient has an alternative source of cerebral embolus, including but not limited to:
- •Patient has chronic atrial fibrillation.
- •Patient has had any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation.
- •Knowledge of any cardiac sources of emboli. (including but not limited to left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcific aortic stenosis, endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma).
- •Recently (<60 days) implanted heart valve (either surgically or endovascularly), which is a known source of emboli as confirmed on echocardiogram.
- •Abnormal angiographic findings: ipsilateral intracranial or extracranial arterial stenosis (as determined by angiography or CTA/MRA ≤ 6 months prior to index procedure) greater in severity than the lesion to be treated, cerebral aneurysm > 5 mm, AVM (arteriovenous malformation) of the cerebral vasculature, or other abnormal angiographic findings.
- •2. Patient has a history of spontaneous intracranial hemorrhage within the past 12 months, or has had a recent (<7 days) stroke of sufficient size (on CT or MRI) to place him or her at risk of hemorrhagic conversion during the procedure.
- •3. Patient had hemorrhagic transformation of an ischemic stroke within the past 60 days.
- •4. Patient with a history of major stroke attributable to either carotid artery (CVA or retinal embolus) with major neurological deficit (NIHSS ≥ 5 OR mRS ≥ 3) likely to confound study endpoints within 1 month of index procedure.
- •5. Patient has an intracranial tumor.
- •Patient has an evolving stroke.
- •Patient has neurologic illnesses within the past two years characterized by fleeting or fixed neurologic deficit which cannot be distinguished from TIA or stroke, including but not limited to: moderate to severe dementia, partial or secondarily generalized seizures, complicated or classic migraine, tumor or other space-occupying brain lesions, subdural hematoma, cerebral contusion or other post-traumatic lesions, intracranial infection, demyelinating disease, or intracranial hemorrhage).
- •8. Patient has had a TIA or amaurosis fugax within 48 hrs prior to the procedure.
- •9. Patient has an isolated hemisphere.
- •Patient had or will have CABG, endovascular stent procedure, valve intervention or vascular surgery within 30 days before or after the intervention.
- •11. Myocardial Infarction within 72 hours prior to the intervention.
- •Presence of a previous placed intravascular stent in target vessel or ipsilateral CCA or significant CCA inflow lesion.
- •13. Occlusion or [Thrombolysis In Myocardial Infarction Trial (TIMI 0)] "string sign" >1cm of the ipsilateral common or internal carotid artery.
- •14. An intraluminal filling defect (defined as an endoluminal lucency surrounded by contrast, seen in multiple angiographic projections, in the absence of angiographic evidence of calcification) whether or not it is associated with an ulcerated target lesion.
- •15. Ostium of Common Carotid Artery (CCA) requires revascularization.
- •Patient has an open stoma in the neck.
- •Female patients who are pregnant or may become pregnant.
- •Patient has history of intolerance or allergic reaction to any of the study medications or stent materials (refer to stent IFU), including aspirin (ASA), ticlopidine, clopidogrel (or other P2Y12 inhibitors) , statin or contrast media (that can't be pre medicated). Patients must be able to tolerate statins and a combination of ASA and ticlopidine or ASA and clopidogrel or ASA and alternative P2Y12 inhibitor (e.g. ticagrelor [Brilinta], prasugrel [Effient]).
- •19. Patient has a life expectancy <1 year (for symptomatic group regardless of surgical risk designation), or <3 years (for asymptomatic HSR group), or < 5 years (for asymptomatic SSR group) without contingencies related to other medical, surgical, or interventional procedures as per the Wallaert Score (for asymptomatic patients) and patients with primary, recurrent or metastatic malignancy who do not have independent assessment of life expectancy performed by the treating oncologist or an appropriate specialist other than the physician performing TCAR.
- •20. Patient has an unresolved or uncorrected bleeding disorder, known bleeding diathesis or hypercoagulable state.
结局指标
主要结局
• Procedural success
时间窗: 30-days of the index procedure
technical success in the absence of a Major Adverse Event
次要结局
未报告次要终点
研究者
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