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临床试验/NCT05607277
NCT05607277已完成不适用

Global Iliac Branch Study (Iliac Conformability Paper, Gore vs. Cook)

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 297 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
297
试验地点
1
主要终点
Device conformability in relation to endovascular repair of abdominal aortoiliac aneurysms.

研究概览

简要总结

This project seeks to determine if certain anatomic factors, specifically tortuous and non-conformable iliac arteries, may predict device complications, including seal zone failure, type III endoleak, and occlusion. Approximately 400 subjects from 5 academic centers across the United States, Europe, and Asia will be included in this study. Various markers of pre- and post-treatment iliac anatomy will be measured using CT imaging, and clinical events will be reported by academic centers. The relationship of imaging data to patient demographics will then be assessed alongside anatomic and demographic predictors of non-conformability.

详细描述

Background and significance Abdominal aortic aneurysms (AAAs) affect 0.5% to 1.3% of women and 4.0% to 7.6% of men age 65 and older1-4. Infrarenal AAAs frequently extend distally through the aortic bifurcation and into the common, external, and/or internal iliac arteries,5,6 presenting a challenge for aneurysm repair. Current guidelines prioritize repair strategies which preserve blood flow to the internal iliac artery (IIA) with the goal of reducing the complications of buttock claudication and pelvic ischemia.7-9 As endovascular intervention has become standard practice for those with eligible anatomy, 7 branched endovascular devices have been developed to preserve IIA blood flow when repairing AAAs with iliac involvement.

With the ongoing development of devices and techniques, the range of iliac anatomy eligible for endovascular repair has increased. Most notably, multiple iliac branch devices (IBDs) are being used to treat AAAs involving highly tortuous iliac arteries. A variety of IBDs are available globally, and as such, there is an opportunity to determine if certain anatomic factors- specifically tortuous and non-conformable iliac arteries- may predict device complications.

To begin exploring this question, the Global Iliac Branch Study (GIBS)- a partnership between 5 centers across the United States, Europe, and Asia- was developed to evaluate performance of branched endografts based on anatomical assessments, with analysis of CT scans using centralized and standardized analysis protocols at the AortaCore Imaging Lab at the University of Wisconsin-Madison.

Previous work In addition to elevated risk of conversion to open repair,10 iliac tortuosity has previously been associated with increased risk of "conformability" events, including seal zone failure, type III endoleak, occlusion, stenosis, compression, and device migration.11-13

Previously, the applicant and her faculty mentor have explored the interaction between iliac tortuosity and device conformability in patients treated with the W.L.GORE EXCLUDER iliac branch endoprosthesis (IBE).14 Non-conformation was defined as a decrease in the total iliac index of tortuosity beyond 15%. This study found that non-conformation, as well as internal iliac artery diameter of less than 10 mm, were associated with adverse iliac events after iliac branch endoprosthesis (odds ratio, 8.2 [P = .02] and odds ratio, 12.3 [P = .02], respectively).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects who have undergone endovascular aortic repair of AAA with iliac involvement via iliac branch device.

排除标准

  • 未提供

结局指标

主要结局

Device conformability in relation to endovascular repair of abdominal aortoiliac aneurysms.

时间窗: 1 day at First post-operative imaging appointment

Adverse events: any radiographic or clinical ipsilateral complication, i.e. dissection, kink, compression, occlusion, endoleaks.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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