NCT01848886

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
301

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 8, 2013

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

5.4 years

First QC Date

February 25, 2013

Last Update Submit

March 13, 2021

Conditions

Complications Due to Coronary Artery Bypass GraftCoronary Artery DiseaseMyocardial IschemiaCoronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Keywords

ERAHEndoscopic Radial Artery HarvestY-graftRadial Artery HarvestTotal Arterial RevascularisationCABGRadial Artery Conduit

Outcome Measures

Primary Outcomes (2)

  • Sum score of hand function questionnaire

    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.

    3 months postoperatively

  • Occurence of cardiac and cerebrovascular events in aortoradial versus mammarioradial grafting

    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.

    1 year postoperatively

Secondary Outcomes (3)

  • 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

Other Outcomes (8)

  • Vascular function in the donor arm of the ERAH and ORAH groups compared to non-donor arms.

    3 months postoperatively

  • Graft patency in ERAH versus ORAH

    1 year postoperatively

  • Graft patency in aortoradial versus mammarioradial grafting

    1 year postoperatively

  • +5 more other outcomes

Study Arms (4)

Grp 1: ERAH, Mammarioradial (Y-graft)

OTHER

Endoscopic radial artery harvest Mammarioradial graft (Y-graft) In this group the radial artery is harvested as an endoscopic procedure and positioned on the heart as an composite graft (Y-graft).

Procedure: Endoscopic radial artery harvestProcedure: Mammarioradial graft (Y-graft)

Grp 2: ERAH, Aortoradial (Free RA)

OTHER

Endoscopic radial artery harvest Aortooradial (free RA) In this group the radial artery is harvested as an endoscopic procedure and positioned on the heart as an free RA graft.

Procedure: Endoscopic radial artery harvestProcedure: Aortoradial graft (Free RA)

Grp 3: ORAH, Mammarioradial (Y-graft)

OTHER

Open radial artery harvest Mammarioradial graft (Y-graft) In this group the radial artery is harvested as an open procedure and positioned on the heart as an composite graft (Y-graft).

Procedure: Open radial artery harvestProcedure: Mammarioradial graft (Y-graft)

Grp 4: ORAH, Aortoradial graft (Free RA)

OTHER

Aortooradial graft (free RA) Open radial artery harvest In this group the radial artery is harvested as an open procedure and positioned on the heart as an free RA graft.

Procedure: Open radial artery harvestProcedure: Aortoradial graft (Free RA)

Interventions

Endoscopic radial artery harvestPROCEDURE

Radial artery harvest is performed as an endoscopic procedure.

Grp 1: ERAH, Mammarioradial (Y-graft)Grp 2: ERAH, Aortoradial (Free RA)
Open radial artery harvestPROCEDURE

Radial artery harvest is performed as an open procedure.

Grp 3: ORAH, Mammarioradial (Y-graft)Grp 4: ORAH, Aortoradial graft (Free RA)
Mammarioradial graft (Y-graft)PROCEDURE

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

Grp 1: ERAH, Mammarioradial (Y-graft)Grp 3: ORAH, Mammarioradial (Y-graft)
Aortoradial graft (Free RA)PROCEDURE

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

Grp 2: ERAH, Aortoradial (Free RA)Grp 4: ORAH, Aortoradial graft (Free RA)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective/sub acute CABG as an isolated procedure.
  • Age \> 18 years
  • Multi-vessel disease
  • Non-dominant arm is eligible for radial artery harvest
  • Written informed consent

You may not qualify if:

  • Geographically not available for follow up
  • Modified Allen's test indicating insufficient ulnary artery perfusion
  • Valve surgery, ablation surgery or any kind of concomitant surgery during same admission.
  • Acute operation (\<24 hours from admission)
  • Dialysis
  • Preoperative neurological deficit on the donor arm
  • LVEF \< 20% preoperative
  • Former sternotomy
  • Contrast allergy
  • Malignant disease
  • No written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (3)

  • Carranza CL, Petersen JJ, Ballegaard M, Werner MU, Hasbak P, Kjaer A, Kofoed KF, Lindschou J, Gluud C, Olsen MH, Engstrom J, Jakobsen JC. Endoscopic or Open Radial Artery Harvest in Coronary Artery Bypass Surgery. NEJM Evid. 2026 Jan;5(1):EVIDoa2500199. doi: 10.1056/EVIDoa2500199. Epub 2025 Dec 23.

    PMID: 41432491DERIVED

  • Carranza CL, Ballegaard M, Werner MU, Hasbak P, Kjaer A, Kofoed K, Olsen MH, Gluud C, Jakobsen JC. Detailed statistical analysis plan for the neurological complications in endoscopic versus open radial artery harvest (NEO) randomised clinical trial. Trials. 2022 Dec 9;23(1):990. doi: 10.1186/s13063-022-06869-7.

    PMID: 36494849DERIVED

  • Carranza CL, Ballegaard M, Werner MU, Hasbak P, Kjaer A, Kofoed KF, Lindschou J, Jakobsen JC, Gluud C, Olsen PS, Steinbruchel DA. Endoscopic versus open radial artery harvest and mammario-radial versus aorto-radial grafting in patients undergoing coronary artery bypass surgery: protocol for the 2 x 2 factorial designed randomised NEO trial. Trials. 2014 Apr 23;15:135. doi: 10.1186/1745-6215-15-135.

    PMID: 24754891DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial IschemiaCoronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Christian L Carranza, MD

    Department of Cardio-Thoracic Surgery, Rigshospitalet, Copenhagen, Denmark

    PRINCIPAL INVESTIGATOR

  • Peter Skov Olsen, MD DMSc

    Department of Cardio-Thoracic Surgery, Rigshospitalet, Copenhagen, Denmark

    STUDY CHAIR

  • Christian Gluud, MD DMSc

    Copenhagen Trial Unit, Rigshospitalet, Copenhagen, Denmark

    STUDY CHAIR

  • Martin Ballegaard, MD PhD

    Department of Clinical Neurophysiology, Rigshospitalet, Copenhagen, Denmark

    STUDY CHAIR

  • Philip Hasbak, MD PhD

    Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, Copenhagen, Denmark

    STUDY CHAIR

  • Andreas Kjær, Prof MD DMSc

    Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, Copenhagen, Denmark

    STUDY CHAIR

  • Klaus F Kofoed, MD DMSc

    Department of Cardiology and Radiology, Rigshospitalet, Copenhagen, Denmark

    STUDY CHAIR

  • Mads Werner, MD, DMSc

    Multidisciplinary Pain Centre, Rigshospitalet, Copenhagen, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Head of Adult Cardiac Surgery, Executive-MBA

Study Record Dates

First Submitted

February 25, 2013

First Posted

May 8, 2013

Study Start

May 1, 2013

Primary Completion

October 1, 2018

Study Completion

November 1, 2020

Last Updated

March 17, 2021

Record last verified: 2021-03

Locations

DK(1)