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临床试验/NCT03530748
NCT03530748Unknown不适用

On-table Renal Perfusion Evaluation for Patients With Renal Artery Stenosis or Aortic Dissection With Renal Artery Obstruction

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年4月9日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
Glomerular Filtration Rate

研究概览

简要总结

  1. Evaluate the feasibility for the on-table evaluation of the renal perfusion by using Syngo Dyna Parenchymal Blood Volume(PBV) Body;
  2. Explore the clinical benefits of this application during procedure to help the physician to determine the procedure endpoint.

详细描述

Renal artery stenosis (RAS) is one of the potential manifestations of peripheral artery diseases and it is often observed in patients with evolving renal function impairment and concomitant coronary artery disease, or in those suffering from hypertension refractory to medical therapy.Percutaneous renal artery stenting is an effective therapeutic tool and represents the treatment of choice for RAS. Identification of parameters able to discriminate patients who benefit from RAS stenting, thus, has become of crucial importance if this technique has to survive.

Aortic dissection represents a common cardiovascular disease and it is responsible for the most commonly encountered pathologies in aortic emergency. Renal dysfunction is a common complication associated with aortic dissection, with resultant high mortality rate. The antegrade propagation of the dissection from the proximal aorta to the level of renal arteries and the intervention during surgery may both increase the risk of renal malperfusion; thus, it is important to assess renal function for pre- and post-operative evaluation and guidance for treatment. This can be achieved through perfusion imaging.

Presently, C-arm Cone Beam Computed Tomography (CBCT) perfusion is well established, in particular, in the diagnostic assessment of acute stroke and cerebral ischemia. The main novelty of our study lies in the fact that intra-procedural renal perfusion assessed for the first time semiquantitatively by Syngo Dyna Parenchymal Blood Volume(PBV) software, discriminate patients who will benefit from the intervention procedure.

In conclusion, our study suggests that a routine assessment of pre, and post-stenting renal perfusion could help to identify patients at higher risk of no improvement or even worsening of renal function after stenting and, perhaps, more aggressive medical therapy.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Renal artery stenosis ≥ 60% and < 100% by doppler ultrasonography, CT angiography or magnetic resonance angiography;
  • Target kidney remains functional (GFR determined);
  • The length of target kidney is >8cm;
  • Resistance index tested by doppler ultrasonography <0.8;
  • Comply with the protocol

排除标准

  • Severe cardiopulmonary insufficiency, hepatic dysfunction, renal inadequacy and clotting mechanism abnormality;
  • Pregnancy or lactation;
  • History of renal artery surgery;
  • Allergy of contrast agent;
  • Other known reason nonischemic kidney disease

结局指标

主要结局

Glomerular Filtration Rate

时间窗: Change from Baseline Glomerular Filtration Rate at 3 months

The golden standard of renal function, tested by radionuclide imaging

次要结局

  • Kidney Volume(10 minutes pre- and post-endovascular therapy on table)
  • Mean Density of Contrast agent(10 minutes pre- and post-endovascular therapy on table)

研究者

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

Zhenyu Shi

Clinical Professor

Shanghai Zhongshan Hospital

研究点 (1)

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