Carotid Artery Revascularization Using TransCarotid flOw Reversal Cerebral Protection And CGUARD MicroNET-Covered Embolic Prevention Stent System to Reduce Strokes in Patients With Symptoms or Signs of Cerebral Ischemia: TOP-GUARD Study
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Immediate procedural success rate
研究概览
简要总结
Prospective, single center clinical study in consecutive patients with symptoms or signs of carotid stenosis related ischemic cerebral injury undergoing carotid revascularization in primary and secondary stroke prevention. MicroNET-covered stent is implanted using direct carotid artery access and temporary flow reversal to combine optimal intraprocedural cerebral protection and optimal plaque exclusion.
详细描述
Prospective, single-center clinical study in consecutive patients undergoing carotid revascularization with MicroNET-covered stent implanted through direct carotid artery access with temporary, intraprocedural flow reversal neuroprotection to provide primary and secondary stroke prevention.
It is an open-label, non-randomized single-arm study supported by the grant from Jagiellonian University Medical college (K/ZDS/007819).
Stroke is a major health problem affecting individual patients and their families and entire societies with death and disability impact (fundamental disability cause in Poland, Europe, and the USA). Atherosclerotic carotid artery stenosis plays an important part in a stroke etiology through embolic and/or hemodynamic mechanism).
Endovascular treatment with first-generation carotid stents is inherently related to plaque and thrombus prolapse through stent struts, as confirmed with the intravascular imaging (IVUS and OCT), and monitoring of cerebral embolism by DW-MRI. Plaque prolapse related embolism may occur after neuroprotection device removal. Postprocedural plaque-prolapse related ischemic events are responsible for 40-60% complications up to 30 days, as indicated by 30-day results of large clinical trials (CAPTURE, CREST, or ICSS).
A successful attempt to address this problem has been an introduction and routine use of MicroNET-covered stent. The MicroNET attached to the metallic stent prevents intraluminal plaque prolapse. MRI imaging indicated a significant reduction of intraprocedural embolism and near-elimination of post-procedural brain embolism by CGuard application. Clinical research and meta-analysis of studies confirmed the safety and efficacy of the stent. Consistent results were demonstrated in registries such as PARADIGM.
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
- •Consecutive adult patients with clinical symptoms and/or signs (on cerebral imaging) of of carotid stenosis-related cerebral ischemic injury eligible for TCAR carotid revascularization according to NeuroVascular Team evaluation and local standards
- •Symptomatic and asymptomatic carotid artery stenosis with ipsilateral ischemic lesions in brain imaging (CT or MRI)
- •Informed written consent
- •Declared compliance and consent to adhere to scheduled follow up and routine long term follow up
- •Angiographic Inclusion Criteria:
- •De novo or neo-atherosclerotic carotid artery lesion
- •NASCET criteria ≥50% carotid artery stenosis in patients with ipsilateral TIA, stroke or amaurosis fugax within last 6 months
- •NASCET criteria ≥70-80% carotid artery stenosis in asymptomatic patients especially with ipsilateral ischemic lesions in brain imaging (CT or MRI)
排除标准
- •Lack of technical feasibility or logistic opportunity to perform procedure (device availability)
- •Life expectancy less than 1 year
- •Renal insufficiency with creatinine >3mg/dL
- •Myocardial infarction within last 72 hours before procedure
- •Pregnant women
- •Coagulopathies
- •Allergy to contrast media not amenable to pharmacotherapy
- •Angiographic Exclusion Criteria:
- •Total carotid artery occlusion
- •Stent in the carotid artery preventing artery cannulation or introduction of stent or protective device
- •Anatomic variants preventing introduction of stent or protective device
- •Significant common carotid artery stenosis proximal to target vessel
- •Moving plaque in aortic arch
结局指标
主要结局
Immediate procedural success rate
时间窗: 48 hours or hospital discharge, whatever comes first
Combined endpoint of TECHNICAL SUCCESS (insertion and removal of the embolic protection device, successful stent delivery, implantation and delivery system retrieval, with residual stenosis ≤30%) AND CLINICAL SUCCESS (freedom from MACNE (death, stroke, myocardial infarction) up to 48 hrs or hospital discharge)
次要结局
- Freedom from MACNE up to 30 days(30 days postprocedural)
- Freedom from MACNE up to 90 days(90 days postprocedural)
- Occurence of new, postprocedural ipsilateral DW-MRI ischemic lesions(90 days post procedure)
- Rate of complete stent expansion and apposition(During procedure)
- Rate of ipsilateral stroke(1 year to 5 years post procedure)
- Rate of any stroke(Up to 5 years post procedure)
- Stroke free survival(Up to 5 years post procedure)
- Ipsilateral stroke free survival(Up to 5 years post procedure)
- Rate of target vessel restenosis requiring treatment(Up to 5 years post procedure)
- Ultrasound measured Peak Systolic Velocity in target artery(At 1 year post-procedure)