Heart DiseasesTSTNCT05562908

Skeletonised Versus Pedicled Internal Thoracic Artery

A study testing Pedicled, Surgical skeletonised and Thunderbeat skeletonised in people with Heart Diseases, run by Lars Peter Riber at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

It is to date unknown whether Thunderbeat has a place in harvesting the left internal mammary artery (LIMA) and whether skeletonisation is superior to pedicle harvested LIMA. Though, some studies have shown improved flow-rates in the skeletonised graft while others shows compromised blood flow to the thoracic wall… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Diseases
What is being tested?: Pedicled, Surgical skeletonised and Thunderbeat skeletonised
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 165 participants
Where: 1 siteDenmark
Study dates: 1 Apr 2019to 30 Nov 2021
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

Stand-alone CABG (surgical removal of the left atrial appendage (LAAX) is accepted, since it doesn't affect the graft area)
On-pump with cardioplegia (otherwise one cannot be sure of the pressure and perfusion during surgery of the graft)
Patients aged >18
Elective surgery (there is a known higher risk of postoperative complications with urgent surgery)

Who cannot join

CABG combined with other heart surgery, except from LAAX
Previous heart surgery
LVEF < 40% (there is a known higher risk of postoperative complications with low LVEF)
Known cancers (there is a known higher risk of postoperative complication)
Thoracic radiation therapy (there is a known higher risk of postoperative complication)
Severe chronic obstructive pulmonary disease (COPD) (there is a known higher risk of postoperative complication)
Patients not able to understand written consent
Urgent and emergent surgery (there is a known higher risk of postoperative complication)

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Department of Cardio, Vascular and Thoracic Surgery
Odense, Region Syddanmark, 5000

Other trials in Denmark

About this study

Official title: Skeletonised Versus Pedicled Internal Thoracic Artery - A Randomised Study

The purpose of this study is to improve the quality of life for patients undergoing coronary artery bypass graft (CABG) operations.

The aim of this study is to compare three groups of LIMA harvesting techniques: Pedicled, surgical skeletonised and skeletonised with Thunderbeat to determine the best way to harvest LIMA during CABG operations.

The study design is an experimental randomized controlled trial in a single centre.

Study population: Adult patients enlisted for elective stand-alone CABG surgery at the Department of Cardiothoracic surgery, Odense University Hospital.

Study Unit: Test-days within subject and subject

The study will address two main hypotheses in CABG patients:

That both the surgical skeletonised and Thunderbeat skeletonised harvesting techniques of LIMA are superior to pedicled harvesting in regards to flowrates and pulsatility index (PI).
Skeletonized harvesting of LIMA graft compared to pedicled harvesting improves patient quality of life three days, 30 days, and six months postoperatively.

Conditions: Heart Diseases
Being tested: Pedicled, Surgical skeletonised, Thunderbeat skeletonised
Keywords: coronary artery diseases, left internal mammary artery, LIMA harvesting, flow, quality of life
Medical subject headings: Heart Diseases, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PedicledProcedure or surgery
Surgical procedure: A prior marking was made on both sides of the LIMA and its veins with bi-polar technique. Hereafter the LIMA and its veins were dissected free with scissor and forceps. Clips were added to all side branches. When the full length of LIMA was obtained, the LIMA and its veins were divided distally by adding clips on the peripheral part of the vessels and proximately dividing by scissor. A vessel-clamp was placed distally and the pedicled LIMA placed in the jugular cavity with a cloth containing papaverine.
Surgical skeletonisedProcedure or surgery
Surgical procedure: The fascia of the LIMA was opened with a scissor. Hereafter the LIMA was dissected free with scissor and forceps, clips on all LIMA side-branches and divided by scissor. When the full length of LIMA was obtained, the LIMA was divided distally by adding clips on the peripheral part of the vessel and proximately dividing by scissor. A vessel-clamp was placed distally, and the skeletonised LIMA placed in the jugular cavity with a cloth containing papaverine.
Thunderbeat skeletonisedProcedure or surgery
Surgical procedure: With Thunderbeat the fascia of LIMA was opened. The LIMA was dissected free with Thunderbeat including all side-branches. When the full length of the LIMA was obtained, the LIMA was divided distally by adding clips on the peripheral part of the vessel and proximately dividing by scissor. A vessel-clamp was placed distally, and the skeletonised LIMA placed in the jugular cavity with a cloth containing papaverine.

Study groups in NCT05562908
Study group	Role	What they receive
Pedicled	Active comparator	Harvesting of LIMA with its surrounding tissue: fascia, veins, etc Receives: Procedure: Pedicled
Surgical skeletonised	Active comparator	Harvesting of LIMA in a "naked" fashion where you dissect the artery free of the surrounding tissue. Receives: Procedure: Surgical skeletonised
Skeletonised with Thunderbeat	Active comparator	Same as Surgical skeletonised but instead of closing the side branches with clips a surgical tool is used for coagulation of the side-branches. Receives: Procedure: Thunderbeat skeletonised

What is being measured

The primary outcome is the main question the study is designed to answer.

Differences in flow in LIMA and pulssatility index between the three groups.
mL/ min With transit time flowmetry (Sono TT flowlab), the graft flow and peripheral index (PI) are measured after weaning off the extracorporeal circulation with a systolic pressure aimed at 100 mmHg. The measurements are done with probe size 3 or 4.
Measured: Perioperative - After weaning off the extracorporeal circulation just before closing the thorax

Secondary outcomes (20)

Postoperative bleeding
Unit: mL
Measured: Postoperative bleeding is measured from the end of the operation to removal of the mediastinal drains in the intensive care unit
Re-operation due to bleeding
Number of patients in each group
Measured: Up to 48 hours calculated from the end of primaery surgery
Re-operation due to ischemia
Number of patients in each group
Measured: Up to 48 hours calculated from the end of primaery surgery
Pleurocentesis
Number of patients in each group
Measured: Up to 10 days calculated from the end of primaery surgery
Myocardial injury - creatine kinase-MB (CK-MB)
Unit: (µg/L)
Measured: Routine bloodsample measured four hours after aortic cross clamp removal.
Myocardial injury - cardiac troponin (cTn)
Unit: (ng/L)
Measured: Routine bloodsample measured four hours after aortic cross clamp removal.
Differences in pre and post operative regional oxygen saturation on the thorax.
Unit: oxygen saturation (rSO2)
Measured: Measured 7 days prior to surgery and again 3 days after surgery
Length of stay on ICU
Unit: Days
Measured: Day of surgery to the day of discharge from ICU. Up to 52 weeks
Length of stay in hospital
Unit: Days
Measured: Day of surgery to the day of discharge from hospital. Up to 52 weeks
EQ-5D-5L questionnaire: differences in self reported assessment of patient quality of life between the 3 groups
Developed by the EURO-QoF group in 1990 to describe five dimensions of quality of life: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems and extreme problems and a visual analogue scale recording the patient's self-rated health.
Measured: Questionnaires uptained the week before the date of surgery and again 3, 30, and 180 days after surgery.
Telephone interview - Questions regarding pain, numbness and wound healing around the thoracic incision.
All questions are closed questions and qualitative variables (yes/no)
Measured: 180 ± 7 days calculated from the date of surgery.
Rate of readmission to hospital due to Major adverse cardiac and cerebrovascular events (MACCE) - early
Number of deaths in each group
Measured: Early (≤30 days)
Rate of readmission to hospital due to Major adverse cardiac and cerebrovascular events (MACCE) - Intermediate
Number of deaths in each group
Measured: Intermediate (≤180 days)
Rate of readmission to hospital due to Major adverse cardiac and cerebrovascular events (MACCE) - Long
Number of deaths in each group
Measured: Long (≤2 years)
Rate of mortality due to cardiac event - Early
Number of deaths in each group
Measured: Early (≤30 days)
Rate of mortality due to cardiac event - Intermediate
Number of deaths in each group
Measured: Intermediate (≤180 days)
Rate of mortality due to cardiac event - Iong
Number of deaths in each group
Measured: Long (≤2 years)
Rate of all-cause mortality - Early
Number of deaths in each group
Measured: Early (≤30 days)
Rate of all-cause mortality - Intermediate
Number of deaths in each group
Measured: Intermediate (≤180 days)
Rate of all-cause mortality - long
Number of deaths in each group
Measured: Long (≤ 2 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201930 Nov 2021

First posted3 Oct 2022
Study start1 Apr 2019
Primary completion30 Apr 2021
Study completion30 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Heart DiseasesStudies of the same condition, open and under way.
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: Parallel groups
Model description: Randomised trial
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 165 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05562908
Sponsor's protocol ID: OP_764
Other IDs: S-20180083
Acronym: TST
Status last verified: Oct 2022
First submitted: 28 Sep 2022
Last updated: 5 Oct 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.

Publications

Melly L, Torregrossa G, Lee T, Jansens JL, Puskas JD. Fifty years of coronary artery bypass grafting. J Thorac Dis. 2018 Mar;10(3):1960-1967. doi: 10.21037/jtd.2018.02.43.
PubMed 29707352
Thuijs DJFM, Kappetein AP, Serruys PW, Mohr FW, Morice MC, Mack MJ, Holmes DR Jr, Curzen N, Davierwala P, Noack T, Milojevic M, Dawkins KD, da Costa BR, Juni P, Head SJ; SYNTAX Extended Survival Investigators. Percutaneous coronary intervention versus coronary artery bypass grafting in patients with three-vessel or left main coronary artery disease: 10-year follow-up of the multicentre randomised controlled SYNTAX trial. Lancet. 2019 Oct 12;394(10206):1325-1334. doi: 10.1016/S0140-6736(19)31997-X. Epub 2019 Sep 2.
PubMed 31488373
Harskamp RE, Lopes RD, Baisden CE, de Winter RJ, Alexander JH. Saphenous vein graft failure after coronary artery bypass surgery: pathophysiology, management, and future directions. Ann Surg. 2013 May;257(5):824-33. doi: 10.1097/SLA.0b013e318288c38d.
PubMed 23574989
Loop FD, Lytle BW, Cosgrove DM, Stewart RW, Goormastic M, Williams GW, Golding LA, Gill CC, Taylor PC, Sheldon WC, et al. Influence of the internal-mammary-artery graft on 10-year survival and other cardiac events. N Engl J Med. 1986 Jan 2;314(1):1-6. doi: 10.1056/NEJM198601023140101.
PubMed 3484393
Sa MP, Cavalcanti PE, Santos HJ, Soares AF, Miranda RG, Araujo ML, Lima RC. Flow capacity of skeletonized versus pedicled internal thoracic artery in coronary artery bypass graft surgery: systematic review, meta-analysis and meta-regression. Eur J Cardiothorac Surg. 2015 Jul;48(1):25-31. doi: 10.1093/ejcts/ezu344. Epub 2014 Sep 15.
PubMed 25228742
Kamiya H, Akhyari P, Martens A, Karck M, Haverich A, Lichtenberg A. Sternal microcirculation after skeletonized versus pedicled harvesting of the internal thoracic artery: a randomized study. J Thorac Cardiovasc Surg. 2008 Jan;135(1):32-7. doi: 10.1016/j.jtcvs.2007.09.004.
PubMed 18179915
Markman PL, Rowland MA, Leong JY, Van Der Merwe J, Storey E, Marasco S, Negri J, Bailey M, Rosenfeldt FL. Skeletonized internal thoracic artery harvesting reduces chest wall dysesthesia after coronary bypass surgery. J Thorac Cardiovasc Surg. 2010 Mar;139(3):674-9. doi: 10.1016/j.jtcvs.2009.03.066. Epub 2009 Sep 22.
PubMed 19775705
Cheng K, Rehman SM, Taggart DP. A Review of Differing Techniques of Mammary Artery Harvesting on Sternal Perfusion: Time for a Randomized Study? Ann Thorac Surg. 2015 Nov;100(5):1942-53. doi: 10.1016/j.athoracsur.2015.06.087. Epub 2015 Sep 26.
PubMed 26410160
Raja SG, Dreyfus GD. Internal thoracic artery: to skeletonize or not to skeletonize? Ann Thorac Surg. 2005 May;79(5):1805-11. doi: 10.1016/j.athoracsur.2004.05.053.
PubMed 15854993
Lamy A, Browne A, Sheth T, Zheng Z, Dagenais F, Noiseux N, Chen X, Bakaeen FG, Brtko M, Stevens LM, Alboom M, Lee SF, Copland I, Salim Y, Eikelboom J; COMPASS Investigators. Skeletonized vs Pedicled Internal Mammary Artery Graft Harvesting in Coronary Artery Bypass Surgery: A Post Hoc Analysis From the COMPASS Trial. JAMA Cardiol. 2021 Sep 1;6(9):1042-1049. doi: 10.1001/jamacardio.2021.1686.
PubMed 34132753
Liberman M, Khereba M, Goudie E, Kazakov J, Thiffault V, Lafontaine E, Ferraro P. Pilot study of pulmonary arterial branch sealing using energy devices in an ex vivo model. J Thorac Cardiovasc Surg. 2014 Dec;148(6):3219-23. doi: 10.1016/j.jtcvs.2014.05.089. Epub 2014 Jul 19.
PubMed 25125207
Lee SW, Jo JY, Kim WJ, Choi DK, Choi IC. Patient and haemodynamic factors affecting intraoperative graft flow during coronary artery bypass grafting: an observational pilot study. Sci Rep. 2020 Jul 31;10(1):12968. doi: 10.1038/s41598-020-69924-w.
PubMed 32737380
Takami Y, Ina H. Effects of skeletonization on intraoperative flow and anastomosis diameter of internal thoracic arteries in coronary artery bypass grafting. Ann Thorac Surg. 2002 May;73(5):1441-5. doi: 10.1016/s0003-4975(02)03501-4.
PubMed 12022530
Mannacio V, Di Tommaso L, De Amicis V, Stassano P, Vosa C. Randomized flow capacity comparison of skeletonized and pedicled left internal mammary artery. Ann Thorac Surg. 2011 Jan;91(1):24-30. doi: 10.1016/j.athoracsur.2010.06.131.
PubMed 21172479
Mazur P, Litwinowicz R, Tchantchaleishvili V, Natorska J, Zabczyk M, Bochenek M, Przybylski R, Iwaniec T, Kedziora A, Filip G, Kapelak B. Left Internal Mammary Artery Skeletonization Reduces Bleeding-A Randomized Controlled Trial. Ann Thorac Surg. 2021 Sep;112(3):794-801. doi: 10.1016/j.athoracsur.2020.10.024. Epub 2020 Nov 7.
PubMed 33171172

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Skeletonised Versus Pedicled Internal Thoracic Artery - A Randomised Study
ClinicalTrials.gov ID: NCT05562908
Acronym / sponsor ID: TST / OP_764
Conditions: Heart Diseases
Keywords: coronary artery diseases, left internal mammary artery, LIMA harvesting, flow, quality of life
Study type: Interventional
Recruitment status: Completed
Enrolment: 165 participants (actual)
Lead sponsor: Lars Peter RiberUniversity, hospital or other
Collaborators: Odense Patient Data Explorative Network, GCP-unit at Odense University Hospital
Study start: 1 Apr 2019 (actual)
Primary completion: 30 Apr 2021 (actual)
Study completion: 30 Nov 2021 (actual)
First posted: 3 Oct 2022 (actual)
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.

The purpose of this study is to improve the quality of life for patients undergoing coronary artery bypass graft (CABG) operations.

The study design is an experimental randomized controlled trial in a single centre.

Study population: Adult patients enlisted for elective stand-alone CABG surgery at the Department of Cardiothoracic surgery, Odense University Hospital.

Study Unit: Test-days within subject and subject

The study will address two main hypotheses in CABG patients:

That both the surgical skeletonised and Thunderbeat skeletonised harvesting techniques of LIMA are superior to pedicled harvesting in regards to flowrates and pulsatility index (PI).
Skeletonized harvesting of LIMA graft compared to pedicled harvesting improves patient quality of life three days, 30 days, and six months postoperatively.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3
Model description: Randomised trial

Arm	Type	Receives
Pedicled	Active comparator	Procedure: PedicledHarvesting of LIMA with its surrounding tissue: fascia, veins, etc
Surgical skeletonised	Active comparator	Procedure: Surgical skeletonisedHarvesting of LIMA in a "naked" fashion where you dissect the artery free of the surrounding tissue.
Skeletonised with Thunderbeat	Active comparator	Procedure: Thunderbeat skeletonisedSame as Surgical skeletonised but instead of closing the side branches with clips a surgical tool is used for coagulation of the side-branches.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Stand-alone CABG (surgical removal of the left atrial appendage (LAAX) is accepted, since it doesn't affect the graft area)
On-pump with cardioplegia (otherwise one cannot be sure of the pressure and perfusion during surgery of the graft)
Patients aged >18
Elective surgery (there is a known higher risk of postoperative complications with urgent surgery)

Key exclusion criteria (8 listed)

CABG combined with other heart surgery, except from LAAX
Previous heart surgery
LVEF < 40% (there is a known higher risk of postoperative complications with low LVEF)
Known cancers (there is a known higher risk of postoperative complication)
Thoracic radiation therapy (there is a known higher risk of postoperative complication)

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
PedicledSurgical procedure: A prior marking was made on both sides of the LIMA and its veins with bi-polar technique. Hereafter the LIMA and its veins were dissected free with scissor and forceps. Clips were added to all side branches. When the full length of LIMA was obtained, the LIMA and its veins were divided distally by adding clips on the peripheral part of the vessels and proximately dividing by scissor. A vessel-clamp was placed distally and the pedicled LIMA placed in the jugular cavity with a cloth containing papaverine.	Procedure or surgery	Pedicled
Surgical skeletonisedSurgical procedure: The fascia of the LIMA was opened with a scissor. Hereafter the LIMA was dissected free with scissor and forceps, clips on all LIMA side-branches and divided by scissor. When the full length of LIMA was obtained, the LIMA was divided distally by adding clips on the peripheral part of the vessel and proximately dividing by scissor. A vessel-clamp was placed distally, and the skeletonised LIMA placed in the jugular cavity with a cloth containing papaverine.	Procedure or surgery	Surgical skeletonised
Thunderbeat skeletonisedSurgical procedure: With Thunderbeat the fascia of LIMA was opened. The LIMA was dissected free with Thunderbeat including all side-branches. When the full length of the LIMA was obtained, the LIMA was divided distally by adding clips on the peripheral part of the vessel and proximately dividing by scissor. A vessel-clamp was placed distally, and the skeletonised LIMA placed in the jugular cavity with a cloth containing papaverine.	Procedure or surgery	Skeletonised with Thunderbeat

Primary outcome

Differences in flow in LIMA and pulssatility index between the three groups.
Time frame: Perioperative - After weaning off the extracorporeal circulation just before closing the thorax
mL/ min With transit time flowmetry (Sono TT flowlab), the graft flow and peripheral index (PI) are measured after weaning off the extracorporeal circulation with a systolic pressure aimed at 100 mmHg. The measurements are done with probe size 3 or 4.

20 secondary outcomes

Postoperative bleeding
Time frame: Postoperative bleeding is measured from the end of the operation to removal of the mediastinal drains in the intensive care unit
Re-operation due to bleeding
Time frame: Up to 48 hours calculated from the end of primaery surgery
Re-operation due to ischemia
Time frame: Up to 48 hours calculated from the end of primaery surgery
Pleurocentesis
Time frame: Up to 10 days calculated from the end of primaery surgery
Myocardial injury - creatine kinase-MB (CK-MB)
Time frame: Routine bloodsample measured four hours after aortic cross clamp removal.
Myocardial injury - cardiac troponin (cTn)
Time frame: Routine bloodsample measured four hours after aortic cross clamp removal.
Differences in pre and post operative regional oxygen saturation on the thorax.
Time frame: Measured 7 days prior to surgery and again 3 days after surgery
Length of stay on ICU
Time frame: Day of surgery to the day of discharge from ICU. Up to 52 weeks
Length of stay in hospital
Time frame: Day of surgery to the day of discharge from hospital. Up to 52 weeks
EQ-5D-5L questionnaire: differences in self reported assessment of patient quality of life between the 3 groups
Time frame: Questionnaires uptained the week before the date of surgery and again 3, 30, and 180 days after surgery.
Telephone interview - Questions regarding pain, numbness and wound healing around the thoracic incision.
Time frame: 180 ± 7 days calculated from the date of surgery.
Rate of readmission to hospital due to Major adverse cardiac and cerebrovascular events (MACCE) - early
Time frame: Early (≤30 days)
Rate of readmission to hospital due to Major adverse cardiac and cerebrovascular events (MACCE) - Intermediate
Time frame: Intermediate (≤180 days)
Rate of readmission to hospital due to Major adverse cardiac and cerebrovascular events (MACCE) - Long
Time frame: Long (≤2 years)
Rate of mortality due to cardiac event - Early
Time frame: Early (≤30 days)
Rate of mortality due to cardiac event - Intermediate
Time frame: Intermediate (≤180 days)
Rate of mortality due to cardiac event - Iong
Time frame: Long (≤2 years)
Rate of all-cause mortality - Early
Time frame: Early (≤30 days)
Rate of all-cause mortality - Intermediate
Time frame: Intermediate (≤180 days)
Rate of all-cause mortality - long
Time frame: Long (≤ 2 years)

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 5 Oct 2022.
Background: PubMed 29707352Melly L, Torregrossa G, Lee T, Jansens JL, Puskas JD. Fifty years of coronary artery bypass grafting. J Thorac Dis. 2018 Mar;10(3):1960-1967. doi: 10.21037/jtd.2018.02.43.
Background: PubMed 31488373Thuijs DJFM, Kappetein AP, Serruys PW, Mohr FW, Morice MC, Mack MJ, Holmes DR Jr, Curzen N, Davierwala P, Noack T, Milojevic M, Dawkins KD, da Costa BR, Juni P, Head SJ; SYNTAX Extended Survival Investigators. Percutaneous coronary intervention versus coronary artery bypass grafting in patients with three-vessel or left main coronary artery disease: 10-year follow-up of the multicentre randomised controlled SYNTAX trial. Lancet. 2019 Oct 12;394(10206):1325-1334. doi: 10.1016/S0140-6736(19)31997-X. Epub 2019 Sep 2.
Background: PubMed 23574989Harskamp RE, Lopes RD, Baisden CE, de Winter RJ, Alexander JH. Saphenous vein graft failure after coronary artery bypass surgery: pathophysiology, management, and future directions. Ann Surg. 2013 May;257(5):824-33. doi: 10.1097/SLA.0b013e318288c38d.
Background: PubMed 3484393Loop FD, Lytle BW, Cosgrove DM, Stewart RW, Goormastic M, Williams GW, Golding LA, Gill CC, Taylor PC, Sheldon WC, et al. Influence of the internal-mammary-artery graft on 10-year survival and other cardiac events. N Engl J Med. 1986 Jan 2;314(1):1-6. doi: 10.1056/NEJM198601023140101.
Background: PubMed 25228742Sa MP, Cavalcanti PE, Santos HJ, Soares AF, Miranda RG, Araujo ML, Lima RC. Flow capacity of skeletonized versus pedicled internal thoracic artery in coronary artery bypass graft surgery: systematic review, meta-analysis and meta-regression. Eur J Cardiothorac Surg. 2015 Jul;48(1):25-31. doi: 10.1093/ejcts/ezu344. Epub 2014 Sep 15.
Background: PubMed 18179915Kamiya H, Akhyari P, Martens A, Karck M, Haverich A, Lichtenberg A. Sternal microcirculation after skeletonized versus pedicled harvesting of the internal thoracic artery: a randomized study. J Thorac Cardiovasc Surg. 2008 Jan;135(1):32-7. doi: 10.1016/j.jtcvs.2007.09.004.
Background: PubMed 19775705Markman PL, Rowland MA, Leong JY, Van Der Merwe J, Storey E, Marasco S, Negri J, Bailey M, Rosenfeldt FL. Skeletonized internal thoracic artery harvesting reduces chest wall dysesthesia after coronary bypass surgery. J Thorac Cardiovasc Surg. 2010 Mar;139(3):674-9. doi: 10.1016/j.jtcvs.2009.03.066. Epub 2009 Sep 22.
Background: PubMed 26410160Cheng K, Rehman SM, Taggart DP. A Review of Differing Techniques of Mammary Artery Harvesting on Sternal Perfusion: Time for a Randomized Study? Ann Thorac Surg. 2015 Nov;100(5):1942-53. doi: 10.1016/j.athoracsur.2015.06.087. Epub 2015 Sep 26.
Background: PubMed 15854993Raja SG, Dreyfus GD. Internal thoracic artery: to skeletonize or not to skeletonize? Ann Thorac Surg. 2005 May;79(5):1805-11. doi: 10.1016/j.athoracsur.2004.05.053.
Background: PubMed 34132753Lamy A, Browne A, Sheth T, Zheng Z, Dagenais F, Noiseux N, Chen X, Bakaeen FG, Brtko M, Stevens LM, Alboom M, Lee SF, Copland I, Salim Y, Eikelboom J; COMPASS Investigators. Skeletonized vs Pedicled Internal Mammary Artery Graft Harvesting in Coronary Artery Bypass Surgery: A Post Hoc Analysis From the COMPASS Trial. JAMA Cardiol. 2021 Sep 1;6(9):1042-1049. doi: 10.1001/jamacardio.2021.1686.
Background: PubMed 25125207Liberman M, Khereba M, Goudie E, Kazakov J, Thiffault V, Lafontaine E, Ferraro P. Pilot study of pulmonary arterial branch sealing using energy devices in an ex vivo model. J Thorac Cardiovasc Surg. 2014 Dec;148(6):3219-23. doi: 10.1016/j.jtcvs.2014.05.089. Epub 2014 Jul 19.
Background: PubMed 32737380Lee SW, Jo JY, Kim WJ, Choi DK, Choi IC. Patient and haemodynamic factors affecting intraoperative graft flow during coronary artery bypass grafting: an observational pilot study. Sci Rep. 2020 Jul 31;10(1):12968. doi: 10.1038/s41598-020-69924-w.
Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.

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Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity

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.

Lars P Riber, MD, Ph.D. DMSc study director

Odense University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Pedicled, Surgical skeletonised and Thunderbeat skeletonised in people with Heart Diseases, run by Lars Peter Riber 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 4 inclusion and 8 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 5 Oct 2022. 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?

Differences in flow in LIMA and pulssatility index between the three groups. (time frame: Perioperative - After weaning off the extracorporeal circulation just before closing the thorax). 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 NCT05562908, which also lists 19 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 5 Oct 2022.