Coronary Arterial Disease (CAD)3DCABGNCT07039838
Cardiac Computed Tomography Based 3-D Printing for Optimized Coronary Artery Bypass Graft Surgery
A study testing 3D print of coronary arteries in people with Coronary Arterial Disease (CAD) and Bypass Graft Occlusion, run by Jesper James Linde at 1 site in Denmark.
Trial summary
Coronary artery bypass graft surgery (CABG) is a preferred surgical treatment in patients with widespread coronary artery disease. However, studies have shown that up to one third of patients will have closure of at least one bypass graft (graft failure) after one year, which has prognostic implications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arterial Disease (CAD), Bypass Graft Occlusion
- What is being tested?
- 3D print of coronary arteries
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2025to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Indication for CABG (with or without valve-surgery), determined by heart team conference. The revascularization plan must include further grafting in addition LIMA to LAD.
Who cannot join
- Age <18 years
- Permanent atrial fibrillation
- Renal failure (eGRF < 30)
- Known allergy to contrast material
- Pregnant and/or breastfeeding
- Indication for acute CABG
- Patients who cannot tolerate premedication with nitroglycerin and beta blocker (including LVEF<40%). This applies only to the pre-operative CT scan.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Rigshospitalet
Copenhagen, 2100
Jesper J Linde, MD, PhD, (+45) 35456396, jesper.james.linde@regionh.dk
Sulman Rafiq, MD, PhD, (+45) 35451174, sulman.rafiq@regionh.dk
About this study
Coronary artery bypass graft surgery (CABG) is a preferred surgical treatment in patients with widespread coronary artery disease. However, studies have shown that up to one third of patients will have closure of at least one bypass graft (graft failure) after one year, which has prognostic implications. Since graft failure can partly be due to inappropriate placement of the distal graft anastomosis, there is a need to develop new surgical methods to ensure optimal placement of the grafts. Three-dimensional (3D) printing is a technique developed to transform digital objects into physical models. The method is widely used in orthopedic surgery and maxillofacial surgery, but has also gained interests in cardiology, and has proved usefull in the preparation for invasive interventions or surgery in patients with complicated anatomy, including congenital heart disease.
The purpose of the study is to investigate, if a surgical strategy, based on a preoperative cardiac CT, including a patient-specific printed 3-D model of the coronary vessels, marked with optimal bypass graft insertion points, can reduce graft failure, assessed by a control cardiac CT examination performed 12 months after surgery. The hypothesis is that 3-D printing of coronary vessels determined from invasive coronary angiography and cardiac CT prior to CABG reduces graft failure 12 months after surgery.
- Being tested
- 3D print of coronary arteries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D print of coronary arteriesDiagnostic test
Based on a pre-surgical cardiac CT the optimal graft insertions points on the target coronary arteries wil be marked and a patient-specific model of the coronary arteries will be 3D-printed and sterialized to be available during CABG to guide the placement of the distal graft anastomosis.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Will undergo CABG as per usual clinical practice |
| 3D-print guided CABG | Experimental | Will have a CT-based 3D-print of the coronary arteries marked with the optimal graft insertion points to be used during CABG Receives: Diagnostic Test: 3D print of coronary arteries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft failure
Difference in the proportion of grafts with graft failure 12 months after surgery. Graft failure is defined as: 1) graft occlusion 2) graft stenosis >50% 3) Graft anastomosis is placed on wrong vessels or proximal to the stenosis 4) String sign (radialis grafts)
Measured: From surgery to the control cardiac CT performed at 12 months
Secondary outcomes (6)
Graft failure at a patient level
Difference in the proportion of patients with graft failure at 12 months
Measured: From surgery to the control cardiac CT performed at 12 months
Occluded grafts
Difference in number of occluded grafts at 12 months (graft level and patient level)
Measured: From surgery to the control cardiac CT at 12 months
Graft stenosis
Difference in proportion of graft stenosis at 12 months (graft level and patient level)
Measured: From surgery to the control cardiac CT at 12 months
Grafts placed on wrong vessels or proximal to coronary stenosis
Difference in the number of grafts placed on wrong vessels or proximal to coronary stenosis (graft level and patient level)
Measured: From surgery to the control cardiac CT at 12 months
Acute myocardial infarction or new revascularization
Acute myocardial infarction or renewed revascularization at 12 months.
Measured: From surgery to the control cardiac CT at 12 months
Hospitalization for chest pain, acute coronary disease, heart failure or death
Hospitalization with chest pain, acute coronary disease, heart failure or death at 12 months
Measured: From surgery to the control cardiac CT at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial Disease (CAD)Studies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jesper James Linde
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor-investigator, Jesper James Linde, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039838
- Sponsor's protocol ID
- H-24070405
- Other IDs
- H-24070405
- Acronym
- 3DCABG
- Status last verified
- Jul 2025
- First submitted
- 18 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not have approval to share patient data with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Computed Tomography Based 3-D Printing for Optimized Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT07039838
- Acronym / sponsor ID
- 3DCABG / H-24070405
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jesper James LindeUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 26 Jun 2025 (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.
Coronary artery bypass graft surgery (CABG) is a preferred surgical treatment in patients with widespread coronary artery disease. However, studies have shown that up to one third of patients will have closure of at least one bypass graft (graft failure) after one year, which has prognostic implications. Since graft failure can partly be due to inappropriate placement of the distal graft anastomosis, there is a need to develop new surgical methods to ensure optimal placement of the grafts. Three-dimensional (3D) printing is a technique developed to transform digital objects into physical models. The method is widely used in orthopedic surgery and maxillofacial surgery, but has also gained interests in cardiology, and has proved usefull in the preparation for invasive interventions or surgery in patients with complicated anatomy, including congenital heart disease.
The purpose of the study is to investigate, if a surgical strategy, based on a preoperative cardiac CT, including a patient-specific printed 3-D model of the coronary vessels, marked with optimal bypass graft insertion points, can reduce graft failure, assessed by a control cardiac CT examination performed 12 months after surgery. The hypothesis is that 3-D printing of coronary vessels determined from invasive coronary angiography and cardiac CT prior to CABG reduces graft failure 12 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Will undergo CABG as per usual clinical practice |
| 3D-print guided CABG | Experimental | Diagnostic Test: 3D print of coronary arteriesWill have a CT-based 3D-print of the coronary arteries marked with the optimal graft insertion points to be used during CABG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Indication for CABG (with or without valve-surgery), determined by heart team conference. The revascularization plan must include further grafting in addition LIMA to LAD.
Key exclusion criteria (7 listed)
- Age <18 years
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 |
|---|---|---|
| 3D print of coronary arteriesBased on a pre-surgical cardiac CT the optimal graft insertions points on the target coronary arteries wil be marked and a patient-specific model of the coronary arteries will be 3D-printed and sterialized to be available during CABG to guide the placement of the distal graft anastomosis. | Diagnostic test | 3D-print guided CABG |
Primary outcome
Graft failure
Time frame: From surgery to the control cardiac CT performed at 12 months
Difference in the proportion of grafts with graft failure 12 months after surgery. Graft failure is defined as: 1) graft occlusion 2) graft stenosis >50% 3) Graft anastomosis is placed on wrong vessels or proximal to the stenosis 4) String sign (radialis grafts)
6 secondary outcomes
Graft failure at a patient level
Time frame: From surgery to the control cardiac CT performed at 12 months
Occluded grafts
Time frame: From surgery to the control cardiac CT at 12 months
Graft stenosis
Time frame: From surgery to the control cardiac CT at 12 months
Grafts placed on wrong vessels or proximal to coronary stenosis
Time frame: From surgery to the control cardiac CT at 12 months
Acute myocardial infarction or new revascularization
Time frame: From surgery to the control cardiac CT at 12 months
Hospitalization for chest pain, acute coronary disease, heart failure or death
Time frame: From surgery to the control cardiac CT at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: No. We do not have approval to share patient data with other researchers
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D print of coronary arteries in people with Coronary Arterial Disease (CAD) and Bypass Graft Occlusion, run by Jesper James Linde 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 1 inclusion and 7 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: opening soon, as of the sponsor's last update on 8 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jesper J Linde, MD, PhD (+4535456396, jesper.james.linde@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft failure (time frame: From surgery to the control cardiac CT performed at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2025.