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临床试验/NCT03620006
NCT03620006已完成不适用

Endovascular Occlusion by Plug of the Prevertebral Subclavian Artery Preparatory to the Surgical or Endovascular Aortic Procedures (SAPE)

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2018年5月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
Major adverse event rate

研究概览

简要总结

This is an observational, no-profit, ambispective study: a retrospective arm will include the cases treated between August 2009 and March 2018, and a prospective arm, investigating patients treated from March 2018 until December 2018. Target study population size is 150 patients between two groups analyzed.

Endovascular occlusion of the prevertebral subclavian artery was first used in the Vascular Surgery Department at San Raffaele Hospital in August 2009. During the initial experience (2009-2014) this technique was used with low frequency. Since 2015, the volume of cases receiving this treatment, has increased and the investigators expect to reach the study population target, by the end of 2018.

The objective of this study is describe the casuistry of endovascular occlusion of the subclavian artery by means of the Amplatzer Vascular plug in the Vascular Surgery Department at San Raffaele Hospital, and to evaluate the efficacy of such procedure.

Moreover, the investigators will evaluate the patency and success rate of the carotid-subclavian bypasses performed at the same time of the analyzed procedure.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

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

入选标准

  • adult patients aged ≥ 18 years,
  • patients candidates for endovascular treatment of subclavian artery occlusion with Amplatzer Vascular Plug

排除标准

  • 未提供

结局指标

主要结局

Major adverse event rate

时间窗: within 30-day

Any stroke or mortality related to the surgical procedure

Technical success rate

时间窗: within 30-day

Technical success rate defined as complete occlusion of the left subclavian artery at postoperative CT scan

次要结局

  • Supra-aortic vessels patency rate(within 5-years)
  • Access site complications requiring secondary adjunctive procedures(within 30-day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bertoglio Luca

Principal Investigator

IRCCS San Raffaele

研究点 (1)

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