Residual Stenosis and Restenosis Following Carotid Endarterectomy With Primary Closure, A Prospective Tracking Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Restenosis ≥50% at 12 months
研究概览
简要总结
This prospective, multicenter observational study aims to evaluate the incidence, timing, and characteristics of residual and recurrent (restenosis) carotid artery stenosis following carotid endarterectomy (CEA) with primary closure. Conducted across several neurosurgical centers in the Czech Republic, the study will include patients undergoing elective CEA who meet standard clinical indications.
Participants will undergo preoperative CT angiography and follow-up imaging at 30 days and 1 year post-surgery. Residual stenosis is defined as ≥50% luminal narrowing detected within 30 days postoperatively, while restenosis is evaluated at later time points. The study will also assess clinical outcomes such as ischemic stroke, TIA, myocardial infarction, and mortality. The standardized surgical technique and harmonized diagnostic algorithm across all centers aim to provide robust data on the performance and durability of primary closure CEA.
详细描述
Study Objective:
The objective of this study is to assess the true incidence of restenosis following CEA in the Czech Republic. A major advantage of this study is the use of standardized surgical procedures across participating centers, along with unified data collection methods and diagnostic algorithms.
Methodology:
Patient Cohort:
All patients meeting the current guideline indications for CEA will be enrolled.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients without matching any of exclusion criteria who underwent cartotid endarterectomy
排除标准
- •Age ≤18 or ≥90 years
- •Previous endarterectomy or stenting
- •Unsuitable vascular anatomy
- •High perioperative risk
- •Contralateral cranial nerve X or XII palsy
- •History of neck irradiation
- •Tandem carotid stenosis or intracranial vascular pathology (e.g., aneurysm or AVM)
- •Absence of signed informed consent
结局指标
主要结局
Restenosis ≥50% at 12 months
时间窗: 12 months
Restenosis ≥50% at 12 months
次要结局
- Restenosis ≥50%(30 days)
- iCMP/TIA/death/MI(1 year)
- Change in modified Rankin Scale (mRS)(1 year)
研究者
Norbert Svoboda
cpt. MD. Norbert Svoboda, PhD., FEBNS
Charles University, Czech Republic