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临床试验/NCT02934087
NCT02934087已完成不适用

Evaluation of a Randomized Comparison of Direct Versus Snare Techniques for Cannulation of Contralateral Gate During an Endovascular Aneurysm Repair (EVAR) Procedure

Minneapolis Heart Institute Foundation2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2011年8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
102
试验地点
2
主要终点
Primary Endpoint: Time to contralateral gate cannulation

研究概览

简要总结

This study will evaluate a randomized comparison of direct versus snare techniques for cannulation of contralateral gate during an endovascular aneurysm repair (EVAR) procedure.

This information will be used to determine if primary snaring is superior to retrograde cannulation in decreasing procedural time and radiation exposure.

详细描述

Endografts currently FDA-approved for abdominal aortic aneurysm (AAA) repair are modular systems,comprised of a main body (Aortic Trunk) and two legs (Ipsilateral Leg Endoprosthesis and a contralateral leg endoprosthesis). In placement of the endograft the main body and ipsilateral limb are deployed from a retrograde common femoral artery approach. From the contralateral femoral artery, cannulation of the contralateral gate is required to deploy the contralateral iliac limb.Cannulation of the contralateral limb gate is the portion of the operation that requires the most "wire skills." Depending on the patients' body type, angulations of the aorta and the size and volume of the AAA, this portion of the procedure can be technically difficult. This portion may become lengthy and discouraging if the surgeon fails to cannulate the gate using a particular approach. Cannulation of the contralateral limb gate from a retrograde femoral artery approach is commonly achieved by first using a maneuverable guidewire and steerable catheter. Antegrade or crossover cannulation involves passing a guidewire from the ipsilateral limb to the contralateral limb gate of the endograft, which can be accomplished with a curved catheter. The wire may be retrieved on the contralateral limb using a snare device. The problem and why it is important -- difficulty in accessing the contralateral gate leads to increase procedural time and excess exposure to radiation. The standard of care is retrograde cannulation with the use of crossover snare techniques as a secondary adjunct if retrograde cannulation fails. In this study we will compare retrograde cannulation to primary snaring.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
None

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

  • Patient is undergoing EVAR repair with a commercially available endograft
  • Willing to give consent
  • Procedure is Elective

排除标准

  • Declines to participate
  • Unable to provide consent
  • Urgent AAA repair
  • Participating in another study

结局指标

主要结局

Primary Endpoint: Time to contralateral gate cannulation

时间窗: Intra-operatively comparing the time to contralateral gate cannulation (snare or retrograde techniques) .

The patient will be randomized to either a snare or retrograde technique in a 1:1 ratio intraoperatively at the time of deployment of the main body of the graft. The timer will be started at 0 when positioning catheter is withdrawn from para-renal position into sac. The timer will be stopped after successful gate cannulation or after 30 minutes of fluoroscopy time.

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 (2)

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