Gamechanger: Development of MRI Based Endovascular Procedures for Vascular Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- EVAR planning: correlation between morphological parameters measured based on MRA and CTA
研究概览
简要总结
An abdominal aortic aneurysm (AAA) is a pathological dilatation of the aorta in the belly which can rupture leading to bleeding within the belly. To prevent rupture elective surgery can be performed. Endovascular repair (EVAR) is a surgical intervention whereby a stent is inserted into the AAA to prevent it from further growth and rupture.
Standard AAA management has several drawbacks. To start: maximum AAA diameter is used to determine upon timing of elective repair but is imprecise in predicting the risk of rupture resulting in an unmet clinical need. Secondly, EVAR outcome and complication occurrence remain unpredictable due to poor prediction ability of computed tomography (CT) and ultrasound (US) utilised in the follow-up protocol. Lastly, patients and physicians are being repeatedly exposed to cumulative radiation toxicity. All these drawbacks could be solved by trading the standard imaging modalities by magnetic resonance imaging (MRI). Within the MARVY, advanced MRI techniques are used to find out if standard imaging techniques could be replaced by MRI in three phases of the AAA management (surveillance, surgery planning and post-operative follow-up). The two most important MRI techniques that will be used are 4D flow MRI and dynamic contrast enhanced (DCE) MRI which give respectively information about the blood flow within the AAA and perfusion of the aortic wall.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with AAA
- •provision of written informed consent
- •Inclusion Criteria for surveillance part:
- •maximum AAA diameter between 3-5 cm
- •not scheduled for aneurysm repair at the time of inclusion
- •Inclusion Criteria for planning part:
- •planned for elective EVAR
- •Inclusion Criteria for follow-up part:
- •ten complication free years after EVAR or sac regression after EVAR; or
- •type I endoleak after EVAR; or
- •type II endoleak after EVAR;
排除标准
- •Supra- or pararenal AAA
- •Inflammatory, infectious or mycotic AAA
- •Vasculitis and connective tissue disease
- •Patients that underwent open surgical repair for their AAA
- •Patients with ruptured AAAs
- •Patients that previously presented with allergic reactions to intravenous contrast agents
- •Exclusion Criteria for surveillance part:
- •previous AAA repair
- •severely reduced renal function
- •previous allergic reactions to intravenous contrast agents
- •Exclusion Criteria for planning part:
- •previous AAA repair
- •Exclusion Criteria for follow-up part:
- •severely reduced renal function
- •previous allergic reactions to intravenous contrast agents
结局指标
主要结局
EVAR planning: correlation between morphological parameters measured based on MRA and CTA
时间窗: half year
The main study parameter for phase B2 (EVAR planning) is the difference between anatomical measurements (lengths and diameters) based on both CTA and MRA. Several quantitative anatomical measurements will be utilised to assess the feasibility of MRA for planning of EVARs.
EVAR follow up: difference in MRI parameters between patients with endoleaks and without
时间窗: 1 year
The main study parameter for phase B3 (EVAR follow-up) is the difference in MRI parameters measured post-operatively in patients with and without EVAR related complications.
Surveillance: correlation between growth rate and MRI derived parameters
时间窗: 1 year
The main study parameter for phase B1 (surveillance) is the correlation between growth rate of the AAA (determinant for the standard of care) and measured MRI parameters acquired with 4D flow MRI and DCE-MRI.
次要结局
未报告次要终点
研究者
Associate Prof. Dr. Kak Khee Yeung
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)