Neurological Complications Comparing Endoscopically vs. Open Harvest of the Radial Artery

Summary

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.

Conditions

• Complications Due to Coronary Artery Bypass Graft
• Coronary Artery Disease
• Myocardial Ischemia
• Coronary Disease
• Heart Diseases
• Cardiovascular Diseases
• Arteriosclerosis
• Arterial Occlusive Diseases
• Vascular Diseases

Interventions

PROCEDURE

Endoscopic radial artery harvest

Radial artery harvest is performed as an endoscopic procedure.

PROCEDURE

Open radial artery harvest

Radial artery harvest is performed as an open procedure.

PROCEDURE

Mammarioradial graft (Y-graft)

The radial artery is used as an composite graft positioned on the internal mammarian artery.

PROCEDURE

Aortoradial graft (Free RA)

The radial artery is used as an free graft positioned on the aorta.

Sponsors & Collaborators

• Rigshospitalet, Denmark

  lead OTHER

Principal Investigators

• Christian L Carranza, MD · Department of Cardio-Thoracic Surgery, Rigshospitalet, Copenhagen, Denmark

• Peter Skov Olsen, MD DMSc · Department of Cardio-Thoracic Surgery, Rigshospitalet, Copenhagen, Denmark

• Christian Gluud, MD DMSc · Copenhagen Trial Unit, Rigshospitalet, Copenhagen, Denmark

• Martin Ballegaard, MD PhD · Department of Clinical Neurophysiology, Rigshospitalet, Copenhagen, Denmark

• Philip Hasbak, MD PhD · Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, Copenhagen, Denmark

• Andreas Kjær, Prof MD DMSc · Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, Copenhagen, Denmark

• Klaus F Kofoed, MD DMSc · Department of Cardiology and Radiology, Rigshospitalet, Copenhagen, Denmark

• Mads Werner, MD, DMSc · Multidisciplinary Pain Centre, Rigshospitalet, Copenhagen, Denmark

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-05-31

Primary Completion

2018-10-31

Completion

2020-11-30

Countries

• Denmark

Study Locations