Complications Due to Coronary Artery Bypass GraftNEONCT01848886
Neurological Complications Comparing Endoscopically vs. Open Harvest of the Radial Artery
A study testing Endoscopic radial artery harvest, Open radial artery harvest and Mammarioradial graft (Y-graft) in people with Complications Due to Coronary Artery Bypass Graft and Coronary Artery Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complications Due to Coronary Artery Bypass Graft, Coronary Artery Disease, Myocardial Ischemia
- What is being tested?
- Endoscopic radial artery harvest, Open radial artery harvest and Mammarioradial graft (Y-graft)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 1 siteDenmark
- Study dates
- May 2013to Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- LVEF < 20% preoperative
- Former sternotomy
- Contrast allergy
- Malignant disease
- No written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
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.
Read the detailed description
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
Trial 1: The experimental procedure in this trial will be endoscopic radial artery harvest (ERAH). The control intervention will be open radial artery harvest (ORAH).
Trial 2: The experimental procedure in this trial will be the technique where the radial artery is sewn onto the mammarian artery as a mammario-radial anastomosis (composite/Y-graft). The control intervention will be the technique of sewing the radial artery directly onto the aorta as an aorto-radial anastomosis (free radial artery).
Inclusion and exclusion criteria
All patients referred to our department for sub acute or elective coronary bypass operation will be eligible for trial inclusion. Inclusion criteria are: 18 years or older; able and willing to give informed consent; multi-vessel disease. Exclusion criteria are: off-pump procedure; multi-procedure (i.e. concomitant valve surgery); contrast allergy; geographically not available for follow-up; Allen's test with insufficient ulnary artery perfusion; no informed consent; acute operation; dialysis; preoperative neurological deficit on the donor arm; left ventricle ejection fraction (LVEF) less than 20%; former sternotomy and malignant disease.
Primary and secondary outcomes
Trial 1: The primary outcome will be evaluation of hand function at three months.
The secondary outcomes will be: occurrence of neurophysiological defects in the donor arm assessed by examination of cutaneous sensibility and measurements of the sensory and motoric nervous conduction velocity preoperatively and after three months; change in subjective cutaneous sensibility assessed by a clinical examination after three months; complications assessed as a composite of haematoma formation, wound dehiscence or infection registered before discharge and after three months.
We will also assess a number of exploratory outcomes (serious adverse events, reoperation for bleeding, revascularisation, myocardial infarction, stroke or death, handgrip strength, muscular function in the hand, scar evaluation, vascular supply to the hand, graft patency and participants subjective evaluation of hand function after 1 year).
Trial 2: The primary outcome will be the occurrence of cardio- or cerebrovascular events during the first year after surgery comparing mammario-radial versus aorto-radial grafts. As an exploratory outcome we will also assess graft patency by multi-slice computer tomography (MSCT) comparing mammarioradial versus aortoradial grafts one year after surgery.
Time schedule
Randomisation will commence after 15th of May 2013. The inclusion period of altogether 300 participants is expected to last three years.
- Conditions
- Complications Due to Coronary Artery Bypass Graft, Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases
- Being tested
- Endoscopic radial artery harvest, Open radial artery harvest, Mammarioradial graft (Y-graft), Aortoradial graft (Free RA)
- Keywords
- ERAH, Endoscopic Radial Artery Harvest, Y-graft, Radial Artery Harvest, Total Arterial Revascularisation, CABG, Radial Artery Conduit
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic radial artery harvestProcedure or surgery
Radial artery harvest is performed as an endoscopic procedure.
Open radial artery harvestProcedure or surgery
Radial artery harvest is performed as an open procedure.
Mammarioradial graft (Y-graft)Procedure or surgery
The radial artery is used as an composite graft positioned on the internal mammarian artery.
Aortoradial graft (Free RA)Procedure or surgery
The radial artery is used as an free graft positioned on the aorta.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Endoscopic radial artery harvest; Procedure: 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. Receives: Procedure: Endoscopic radial artery harvest; Procedure: 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). Receives: Procedure: Open radial artery harvest; Procedure: 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. Receives: Procedure: Open radial artery harvest; Procedure: Aortoradial graft (Free RA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year postoperatively
Secondary outcomes (3)
Complications in the donor arm in ERAH versus ORAH
Occurrence of complications at three months after surgery. Complications are defined as a composite of haematoma formation, wound dehiscence, or infection will be compared.
Measured: 3 months postoperatively
Clinical neurological examination in donor arm ERAH versus ORAH
Clinical examination of subjective cutaneous sensibility will be compared between ERAH versus ORAH groups.
Measured: 3 months postoperatively
Neurological deficits in ERAH versus ORAH
Occurence of deficits in following neurological exams will be compared between ERAH and ORAH
- Cutaneous sensibility on both forearms and hands by appraisal of dermatomes. All sensibility modalities are examined:
- Cutaneous touch sensibility examined by Von Fray hair
- Deep pain sensibility examined by algometry.
- Sensory nervous conduction velocity examined on both forearms and hands:
- N. medianus (dig. II - hdl); orthodromic technique
- N. ulnaris (dig. V - hdl); orthodromic technique
- N. radialis (antebrachium - tabatiere); antidromic technique
- N. cutaneous antebrachium lateralis (elbow - antebrachium); antidromic technique
- N. cutaneous antebrachium medialis (elbow - antebrachium); antidromic technique
- Motoric nervous conduction velocity examined on both forearms and hands:
- N. medianus (hdl - m. abductor policis brevis (APB), elbow - APB)
- N. ulnaris (hdl - m. abductor digiti minimi)
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2018
- Study completionNov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Complications Due to Coronary Artery Bypass GraftStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Lildal Carranza, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Christian L Carranza, MD, Principal investigator, Department of Cardio-Thoracic Surgery, Rigshospitalet, Copenhagen, DenmarkPeter Skov Olsen, MD DMSc, Study chair, Department of Cardio-Thoracic Surgery, Rigshospitalet, Copenhagen, DenmarkChristian Gluud, MD DMSc, Study chair, Copenhagen Trial Unit, Rigshospitalet, Copenhagen, DenmarkMartin Ballegaard, MD PhD, Study chair, Department of Clinical Neurophysiology, Rigshospitalet, Copenhagen, DenmarkPhilip Hasbak, MD PhD, Study chair, Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, Copenhagen, DenmarkAndreas Kjær, Prof MD DMSc, Study chair, Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, Copenhagen, DenmarkKlaus F Kofoed, MD DMSc, Study chair, Department of Cardiology and Radiology, Rigshospitalet, Copenhagen, DenmarkMads Werner, MD, DMSc, Study chair, Multidisciplinary Pain Centre, Rigshospitalet, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848886
- Sponsor's protocol ID
- H-3-2012-116
- Other IDs
- H-3-2012-116
- Acronym
- NEO
- Status last verified
- Mar 2021
- First submitted
- 25 Feb 2013
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 41432491Carranza 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.
PubMed 36494849Carranza 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.
PubMed 24754891
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT01848886
- Acronym / sponsor ID
- NEO / H-3-2012-116
- Conditions
- Complications Due to Coronary Artery Bypass Graft, Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases
- Keywords
- ERAH, Endoscopic Radial Artery Harvest, Y-graft, Radial Artery Harvest, Total Arterial Revascularisation, CABG, Radial Artery Conduit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Oct 2018 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 8 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Trial 1: The experimental procedure in this trial will be endoscopic radial artery harvest (ERAH). The control intervention will be open radial artery harvest (ORAH).
Trial 2: The experimental procedure in this trial will be the technique where the radial artery is sewn onto the mammarian artery as a mammario-radial anastomosis (composite/Y-graft). The control intervention will be the technique of sewing the radial artery directly onto the aorta as an aorto-radial anastomosis (free radial artery).
Inclusion and exclusion criteria
All patients referred to our department for sub acute or elective coronary bypass operation will be eligible for trial inclusion. Inclusion criteria are: 18 years or older; able and willing to give informed consent; multi-vessel disease. Exclusion criteria are: off-pump procedure; multi-procedure (i.e. concomitant valve surgery); contrast allergy; geographically not available for follow-up; Allen's test with insufficient ulnary artery perfusion; no informed consent; acute operation; dialysis; preoperative neurological deficit on the donor arm; left ventricle ejection fraction (LVEF) less than 20%; former sternotomy and malignant disease.
Primary and secondary outcomes
Trial 1: The primary outcome will be evaluation of hand function at three months.
The secondary outcomes will be: occurrence of neurophysiological defects in the donor arm assessed by examination of cutaneous sensibility and measurements of the sensory and motoric nervous conduction velocity preoperatively and after three months; change in subjective cutaneous sensibility assessed by a clinical examination after three months; complications assessed as a composite of haematoma formation, wound dehiscence or infection registered before discharge and after three months.
We will also assess a number of exploratory outcomes (serious adverse events, reoperation for bleeding, revascularisation, myocardial infarction, stroke or death, handgrip strength, muscular function in the hand, scar evaluation, vascular supply to the hand, graft patency and participants subjective evaluation of hand function after 1 year).
Trial 2: The primary outcome will be the occurrence of cardio- or cerebrovascular events during the first year after surgery comparing mammario-radial versus aorto-radial grafts. As an exploratory outcome we will also assess graft patency by multi-slice computer tomography (MSCT) comparing mammarioradial versus aortoradial grafts one year after surgery.
Time schedule
Randomisation will commence after 15th of May 2013. The inclusion period of altogether 300 participants is expected to last three years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Grp 1: ERAH, Mammarioradial (Y-graft) | Other | Procedure: Endoscopic radial artery harvest, Procedure: Mammarioradial graft (Y-graft)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). |
| Grp 2: ERAH, Aortoradial (Free RA) | Other | Procedure: Endoscopic radial artery harvest, Procedure: Aortoradial graft (Free RA)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. |
| Grp 3: ORAH, Mammarioradial (Y-graft) | Other | Procedure: Open radial artery harvest, Procedure: Mammarioradial graft (Y-graft)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). |
| Grp 4: ORAH, Aortoradial graft (Free RA) | Other | Procedure: Open radial artery harvest, Procedure: Aortoradial graft (Free RA)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic radial artery harvestRadial artery harvest is performed as an endoscopic procedure. | Procedure or surgery | Grp 1: ERAH, Mammarioradial (Y-graft), Grp 2: ERAH, Aortoradial (Free RA) |
| Open radial artery harvestRadial artery harvest is performed as an open procedure. | Procedure or surgery | Grp 3: ORAH, Mammarioradial (Y-graft), Grp 4: ORAH, Aortoradial graft (Free RA) |
| Mammarioradial graft (Y-graft)The radial artery is used as an composite graft positioned on the internal mammarian artery. | Procedure or surgery | Grp 1: ERAH, Mammarioradial (Y-graft), Grp 3: ORAH, Mammarioradial (Y-graft) |
| Aortoradial graft (Free RA)The radial artery is used as an free graft positioned on the aorta. | Procedure or surgery | Grp 2: ERAH, Aortoradial (Free RA), Grp 4: ORAH, Aortoradial graft (Free RA) |
Primary outcome
Sum score of hand function questionnaire
Time frame: 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.
Occurence of cardiac and cerebrovascular events in aortoradial versus mammarioradial grafting
Time frame: 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.
3 secondary outcomes
Complications in the donor arm in ERAH versus ORAH
Time frame: 3 months postoperatively
Clinical neurological examination in donor arm ERAH versus ORAH
Time frame: 3 months postoperatively
Neurological deficits in ERAH versus ORAH
Time frame: 3 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Derived from this study: PubMed 41432491Carranza 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.
- Derived from this study: PubMed 36494849Carranza 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.
- Derived from this study: PubMed 24754891Carranza 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian L Carranza, MD principal investigator
Department of Cardio-Thoracic Surgery, Rigshospitalet, Copenhagen, Denmark
Peter Skov Olsen, MD DMSc study chair
Department of Cardio-Thoracic Surgery, Rigshospitalet, Copenhagen, Denmark
Christian Gluud, MD DMSc study chair
Copenhagen Trial Unit, Rigshospitalet, Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic radial artery harvest, Open radial artery harvest and Mammarioradial graft (Y-graft) in people with Complications Due to Coronary Artery Bypass Graft and Coronary Artery Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sum score of hand function questionnaire (time frame: 3 months postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01848886, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.