跳至主要内容
临床试验/NCT01848886
NCT01848886已完成不适用

Endoscopic Versus Open Radial Artery Harvest and Mammario-radial Versus Aorto-radial Grafting in Patients Undergoing Coronary Artery Bypass Surgery (The 2x2 Factorial Designed Randomised NEO Trial)

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 301 人开始时间: 2013年5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
301
试验地点
2
主要终点
Occurence of cardiac and cerebrovascular events in aortoradial versus mammarioradial grafting

研究概览

简要总结

Coronary artery bypass grafting (CABG) using the radial artery (RA) has since the nineties gone through a revival. The initially reported worse outcome in RA graft patients compared to patients grafted with the saphenous vein (SV) has since been corrected. Studies have shown better patency when using RA, so the RA is going to be preferred more and more especially in younger patients where long time patency is critical. During the last 10 years endoscopic techniques to harvest the RA have evolved. Multiple different techniques have been used, but now the equipment and technique have been refined and are highly reliable. The investigators hypothesize that the endoscopic technique has less complications and a just as good patency as open harvest. There are also two possible ways to use the RA as a graft. One way is sewing it onto the aorta and another way is sewing it onto the mammarian artery. The investigators hypothesize that using it on the mammarian artery is superior as a revascularisation technique with just as good a patency as sewing it directly onto the aorta.

详细描述

Objectives

The present trial will in patients undergoing CABG (1) evaluate the complications in endoscopic versus traditionally harvested radial arteries, (2) evaluate graft patency in endoscopic harvested radial arteries versus open technique, and (3) evaluate the use of mammario-radial grafting versus aorto-radial grafting.

Design and trial size

The NEO Trial is a randomised clinical trial with a 2x2 factorial design. We plan to randomise 300 participants into four intervention groups: (1) mammario-radial endovascular group; (2) aorto-radial endovascular group; (3) mammario-radial open group and (4) aorto-radial open group. A subgroup of 100 participants will be selected to undergo a special scanning of the vascular perfusion of donor and control hands (MIBI scan). The evaluation of graft patency and ischaemia in the arm will be blinded but the assessment of the primary outcome of handfunction at three months is non-blinded evaluated by questionnaire.

Trial interventions

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Occurence of cardiac and cerebrovascular events in aortoradial versus mammarioradial grafting

时间窗: 1 year postoperatively

Occurrence of one of the following cardiac or cerebrovascular events: all cause mortality, myocardial infarction (MI), target vessel revascularisation (TVR) or stroke at one year postoperatively will be compared.

Sum score of hand function questionnaire

时间窗: 3 months postoperatively

Using Likert-type scale scoring system quality of life is assessed after radial artery harvest. The mean values in the ERAH group will be compared to the mean value in the ORAH group at three months after surgery.

次要结局

  • Complications in the donor arm in ERAH versus ORAH(3 months postoperatively)
  • Clinical neurological examination in donor arm ERAH versus ORAH(3 months postoperatively)
  • Neurological deficits in ERAH versus ORAH(3 months postoperatively)

研究者

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

Christian Lildal Carranza

MD, Head of Adult Cardiac Surgery, Executive-MBA

Rigshospitalet, Denmark

研究点 (2)

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