The PET-EVAR Study - Predicting Endoleaks Following Endovascular Aortic Aneurysm Repair Using 18F-Sodium Fluoride
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 4
- 主要终点
- Microcalcification activity in stented and aneurysmal aorta
研究概览
简要总结
The purpose of the study is to describe Sodium Fluoride uptake (using Positron Emission Tomography-Computed Tomography - PET-CT) following Endovascular Aneurysm Repair (EVAR) and to determine whether Sodium Fluoride PET-CT can predict the development of endoleaks.
详细描述
Abdominal aortic aneurysms are a leading cause of death in the United Kingdom. Surveillance programmes and pre-emptive surgical repair are lifesaving. Traditional open surgical repair is associated with major perioperative morbidity and mortality and there has been a move towards minimally invasive Endovascular Aneurysm Repair (EVAR), which reduces these early risks. However, the cost effectiveness and long-term clinical effectiveness of EVAR is undermined by concerns of durability due to the development of endoleaks and late aneurysm rupture secondary to progression of native aortic aneurysm disease and stent graft failure. It has previously been demonstrated that 18F-Sodium Fluoride Positron Emission Tomography can predict progression of aneurysm disease and is associated with greater rates of abdominal aortic aneurysm expansion and the future risk of rupture or surgical repair.
The investigators here wish to examine whether 18F-Sodium Fluoride on Positron Emission Tomography uptake (i) is increased in patients with endoleaks or related complications, (ii) can prospectively predict the likelihood of developing endoleaks in patients undergoing EVAR, and (ii) is a feasible approach to select patients for EVAR with a reduced future risk of stent graft failure and re-intervention. The investigators believe that there is a compelling scientific rationale for this approach with major translational potential to better select subgroups of patients for EVAR and ultimately improve their outcome.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of AAA as defined by the European Society of Vascular Surgery guidelines on the management of aorto-iliac artery aneurysms, and having undergone endovascular repair within the recommended Instructions For Use (IFU) by the manufacturer. ['Endoleak' and 'No Endoleak groups only]
- •Complication will be defined as any type of endoleak or stent graft migration ['Endoleak' group only].
- •A diagnosis of AAA requiring endovascular repair OR a diagnosis of juxtarenal AAA requiring fenestrated endovascular aneurysm repair as defined by the European Society of Vascular surgery guidelines on the management of aorto-iliac artery aneurysms and planned EVAR or fenestrated EVAR surgery. ['pre-EVAR' group only]
- •Minimum age: 50 years. No maximum age.
- •Retain capacity for informed consent
排除标准
- •The inability of patients to undergo PET/CT scanning
- •Chronic kidney disease (eGFR ≤ 30 mL/min/1.73 m2)
- •Major or untreated cancer
- •Pregnancy
- •Allergy or contra-indication to iodinated contrast
- •Inability or unwillingness to give informed consent
- •Life-expectancy of less than two years
- •Known history of connective tissue disease
结局指标
主要结局
Microcalcification activity in stented and aneurysmal aorta
时间窗: 12 months
Will be measured as 18F Sodium Fluoride binding in the aorta. Uptake will be quantified in Standardised Uptake Values and as a tissue to background ratios.
次要结局
- Pattern of microcalcification activity in the stented aorta(12 months)
- Intensity of microcalcification activity in the stented aorta(12 months)
- Endoleaks(12 months)
- Stent graft migration(12 months)
- Aneurysm sac diameter(12 months)
- Aneurysm-related mortality(24 months)
- Neck diameter and neck angulation(12 months)
- Geometry: tortuosity, curvature, torsion(12 months)
- Re-intervention(24 months)
- All-cause mortality(24 months)