Prospective Observational Study of CGuard MicroNet Covered Stent System Use as a Flow Diverter in the Endovascular Exclusion of Carotid Artery Aneurysms. (CGuard Divert-and-HEAL C-HEAL)
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Rate of successful aneurysm exclusion
研究概览
简要总结
Non-randomized, single arm, open label, academic observational study of CGuard MicroNet covered stent system use to achieve endovascular lumen reconstruction in carotid artery aneurysms with indications for treatment (enlarging and/or dissecting / symptomatic).
Jagiellonian University Medical College research project.
详细描述
Carotid artery aneurysm (CAA) is a relatively infrequent, but significant clinical condition with numerous diagnostic and therapeutic implications. CAA affects laminal flow in the carotid artery implicating the risk of thrombus formation in the aneurysm cavity, and subsequent ischemic stroke from distal embolization. Another important clinical problem related to the CAA is a possible aneurysm dissection and rupture. Symptomatic CAA and increasing dimensions of CAA institute unquestioned indications for the CAA treatment.
Surgical carotid aneurysm repair bears a significant risk (periprocedural stroke, cranial nerve damage, carotid artery ligation). Therefore endovascular techniques of CAA exclusion were developed. Covered stents, stent-grafts, and combined stenting and aneurysm embolization with coils were applied. However, covered stents were demonstrated to increase the restenosis risk, and other complications such as CAA neck endo-leak.
Newer technique involves the flow diversion by implantation of stent in dense-structured stent (such as Wallstent) or stent-in-stent implantation. In this case a luminary flow dominates over aneurysm filling, which is limited by stent structure. Gradual thrombosis and occlusion of aneurysm cavity and healing of aneurysm follows.This method disadvantage was related to necessity of double stent load and increased restenosis risk (double metal layer).
These issues were addressed only recently by the double layer mesh stents that demonstrate natural flow diverting capabilities. CGuard Stent system is a self-expandable stent covered with PET mesh (MicroNet) that prevents plaque protrusion into the vessel lumen. In addition, in low flow conditions MicroNet can act as the flow diverter. These stents are routinely implanted in elevated risk plaques in high reference centers in Europe.
Several published observations indicate the CGuard stent also demonstrates flow-diverting capabilities, but the systematic observation of such application was not performed.
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
- •Patients older than 18 years, eligible for endovascular carotid artery aneurysm treatment with Micronet covered stent per Vascular Team evaluation, according to local standards
- •Written, informed consent to participate
- •Agreement to attend protocol required (standard) follow up visits and examinations
排除标准
- •Preferred treatment other than stenting (surgery or conservative treatment / observation) per Vascular Team evaluation
- •Life expectancy <1 year (e.g. active neoplastic disease).
- •Chronic kidney disease with creatinine > 3.0 mg/dL.
- •Myocardial infarction in 72 hours proceeding the stenting procedure (if possible, postponing the procedure)
- •Pregnancy (positive pregnancy test)
- •Coagulopathy.
- •History of uncontrolled contrast media intolerance
- •Angiographic
- •Inclusion Criteria:
- •Carotid artery aneurysm confirmed on angiography - symptomatic, dissected or enlarging
- •Aneurysm eligible for endovascular treatment per Vascular Team evaluation (according to current standards, guidelines and study center practice)
- •Exclusion Criteria:
- •Unsuccessful true lumen engagement
- •Aneurysm neck anatomy precluding healthy-to-healthy coverage with stent
- •Anatomic variants precluding stent implantation
- •Mobile (free-floating) plaque elements in aorta or arteries proximal to target lesion
结局指标
主要结局
Rate of successful aneurysm exclusion
时间窗: 6 months
Successful aneurysm cavity exclusion and endovascular lumen reconstruction on routine, non-invasive CT angiography
次要结局
- Rate of procedural success(Peri-procedural)
- Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in target vessel segment(24 months)
- Number of peri-procedural complications(48 hrs or until discharge)
- Rate of clinical efficacy at 12 months(12 months)
- MACNE at 30 days(30 days)
- Rate of In-hospital MACNE (major adverse cardiac and neurological events)(48 hrs or until discharge)
- Rate of clinical efficacy at 6 months(6 months)
- Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in the target vessel segment(6 months)