跳至主要内容
临床试验/NCT06715930
NCT06715930进行中(未招募)不适用

Nomogram for Predicting In-stent Stenosis After Pipeline Embolization Device Treatment in Patients with Intracranial Aneurysm: a Multicenter, Retrospective Model Development and Validation Study

Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2016年4月1日最近更新:
适应症

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

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

发起方
Beijing Tiantan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ming Lv

MD

Beijing Tiantan Hospital

研究点 (1)

Loading locations...

相似试验

Nomogram for Predicting In-stent Stenosis After... | 临床试验