Nomogram for Predicting In-stent Stenosis After Pipeline Embolization Device Treatment in Patients with Intracranial Aneurysm: a Multicenter, Retrospective Model Development and Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- In-stent stenosis
研究概览
简要总结
Intracranial aneurysms (IAs) are the primary cause of non-traumatic subarachnoid hemorrhage with high morbidity and mortality. Flow diverters, such as pipeline embolization devices (PEDs), are among the most effective methods for treating IAs in recent years due to the maturity of interventional devices and minimally invasive techniques. Unlike conventional stents, PEDs modify the hemodynamics within the parent artery and aneurysm sac, allowing blood flow from the aneurysm sac, thus facilitating endothelialization of the aneurysm neck. As a result, aneurysms are completely removed from circulation with time. However, about 5.1%-38.5% of IA patients develop in-stent stenosis (ISS) even after successful PED implantation. ISS increases the risk of retreatment and ischemic complications, thereby affecting the long-term prognosis of IA patients. Therefore, preoperative determination of the patient's suitability for PED implantation can enhance patient-centered decision-making and improve the long-term prognosis of IA patients.
Although previous studies have evaluated the correlation between certain individual variables and ISS, there are few comprehensive models predicting ISS after PED treatment. Nomograms have been widely used for prediction of tumor survival and cardiovascular events. Nomograms incorporate multiple risk factors for predicting the patient's potential prognosis based on their individual risks. This study aimed to identify the predictors for ISS after PED treatment and to create and verify a nomogram for assessing individual risk.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged18 to 75 years;
- •IAs patients treated with PEDs;
- •patients whose parent artery did not have significant atherosclerotic stenosis;
- •patients who had at least one digital subtraction angiography (DSA) follow-up.
排除标准
- •Patients missing critical clinical baseline;
- •patients with inadequate DSA image quality for reliable assessment;
- •patients with comorbid cerebrovascular conditions, including arteriovenous fistulas and arteriovenous malformations;
- •patients without any follow-up information.
结局指标
主要结局
In-stent stenosis
时间窗: 6 months, 1 year, and 3 years after treatment.
In-stent stenosis was defined as a growth process exceeding the limits of metal mesh, as evidenced by a visible gap between the contrast-filled vascular lumen and the internal contours of the PED.
次要结局
- Complete occlusion at the last angiographic follow-up(6 months, 1 year, and 3 years after treatment)
- Procedure-related complications(6 months, 1 year, and 3 years after treatment)
研究者
Ming Lv
MD
Beijing Tiantan Hospital
