Significant Coronary Artery DiseaseNCT01496664
Coronary Hybrid Revascularisation Study
A study testing Combined CABG and PCI in people with Significant Coronary Artery Disease, run by Aarhus University Hospital Skejby at 1 site in Denmark.
Trial summary
The purpose of the registry is to assess results of combined operative and catheter based (hybrid procedure) treatment of patients with significant coronary artery disease using essential clinical and angiographic parameters. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Significant Coronary Artery Disease
- What is being tested?
- Combined CABG and PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2010to Dec 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Stable, unstable angina pectoris and ACS.
- Significant stenosis of LAD, segment 1 or 2 and of other coronary arteries.
- The patient can be treated with a mammary graft to LAD and by balloon or stent of other lesions.
- Signed informed consent must be available.
Who cannot join
- Earlier cardiac surgery
- Treatment with coronary stent within one year.
- ST-elevation infarction within 24 hours.
- Coronary artery lesions located to LAD, segment 1 or 2, which cannot be treated by coronary bypass operation.
- Stenosis of diagonal branches, CX artery and the right coronary artery, which cannot be treated by PCI.
- Expected survival <1 year following successful treatment.
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- Allergy to aspirin, clopidogrel, ticlopidine and/or prasugrel.
- Allergy to sirolimus, everolimus, zotarolimus og biolimus
- For the patients treated with coronary hybrid intervention in the same seance further exclusion criteria:
- Known disorder of the bloods ability to coagulate (such as renal failure (dialysis or renal creatinine clearance < 50ml/min), congenital coagulopathy, needs for anticoagulant treatment before surgery) Previous gastrointestinal bleeding or previous cerebral
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coronary Hybrid Revascularisation Study Registry on Treatment of Significant Coronary Artery Disease by Combined Bypass Operation (CABG) and Catheter Based Treatment (PCI)
The purpose of the registry is to assess results of combined operative and catheter based (hybrid procedure) treatment of patients with significant coronary artery disease using essential clinical and angiographic parameters.
Based on existing literature we expect the results of coronary artery bypass grafting of the anterior descendent coronary artery (LAD), segment 1 and 2, using the so-called mammary artery graft, to be superior to stent treatment of the same artery.
Read more
At the same time a catheter based intervention using balloon, bare metal stents (BMS) or drug eluting stents (DES) seems to be a better treatment that a saphenous vein graft for other coronary arteries than the LAD. I.e. the right coronary artery (RCA) and the left circumflex coronary artery (CX).
Therefore, we expect a combination of the mentioned surgical and catheter based techniques to be a better treatment than bypass operation or catheter based intervention alone.
Read the detailed description
A total of 150 consecutive patients will be included in the study. The patients will have a coronary artery narrowing located to the LAD, which can be treated with a mammary graft, and a stenosis located to other coronary arteries (RCA and CX), which can be treated by balloon or stent.
The patients included in the study will be recruited from patients who are referred to the Department of Cardiology/Department of Thoracic Surgery, Aarhus University Hospital, Skejby for treatment of significant coronary artery disease. We will not announce for patients, and the patients will not receive a honorarium for participation.
The first 100 patients will be treated i two seances; operation and stent treatment with few days interval. The last 50 patients will be treated in a hybrid operation room with operation and stent treatment in the same seance.
- Conditions
- Significant Coronary Artery Disease
- Being tested
- Combined CABG and PCI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined CABG and PCIProcedure or surgery
Coronary artery bypass grafting Percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| Result of combined CABG and PCI treatment | Experimental | The registry is to assess results of combined operative and catheter based (hybrid procedure) treatment of patients with significant coronary artery disease using essential clinical and angiographic parameters. Receives: Procedure: Combined CABG and PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined endpoint of death, stroke, MI and new revascularisation (PCI or CABG) MACCE
Measured: After 1 year
Secondary outcomes (12)
Combined endpoint of death, stroke, MI and new revascularisation.
Measured: After 1 month and after 1, 3 and 5 years
Individual endpoints of death, stroke, MI and new revascularisation.
Measured: After 1 month and after 1, 3 and 5 years
Death
Measured: Baseline, 1 month, 1, 2, 3, 4 and 10 years
Procedure related biomarker release
Measured: Baseline, 1, 3 and 5 year
Reoperation for bleeding
Measured: Baseline, 1, 3 and 5 year
Operation for suspected sternal infection
Measured: Baseline, 1, 3 and 5 year
CT verified pulmonary embolism
Measured: Baseline, 1, 3 and 5 year
CCS angina class
Measured: 1, 3 and 5 year
NYHA function class
Measured: 1, 3 and 5 year
Duration of hospitalisation related to the index treatment
Measured: Baseline
Duration of admission for the index treatment
Measured: Baseline
Angiographic endpoints
Presence of significant narrowing or occlusion of mammary or vein graft, or lesions treated with stent or balloon.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study startSep 2010
- Primary completionSep 2015
- Study completionDec 2022
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 Significant Coronary Artery DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evald Hoej Christiansen, Aarhus University Hospital Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496664
- Sponsor's protocol ID
- M-20100152
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2011
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rimestad JM, Christiansen EH, Modrau IS. One-year cost-effectiveness and safety of simultaneous hybrid coronary revascularization versus conventional coronary artery bypass grafting. Interact Cardiovasc Thorac Surg. 2019 Aug 1;29(2):217-223. doi: 10.1093/icvts/ivz083. Epub 2019 Mar 21.
PubMed 30903175Modrau IS, Holm NR, Maeng M, Botker HE, Christiansen EH, Kristensen SD, Lassen JF, Thuesen L, Nielsen PH; Hybrid Coronary Revascularization Study Group. One-year clinical and angiographic results of hybrid coronary revascularization. J Thorac Cardiovasc Surg. 2015 Nov;150(5):1181-6. doi: 10.1016/j.jtcvs.2015.08.072. Epub 2015 Aug 28.
PubMed 26432721Modrau IS, Nielsen PH, Botker HE, Christiansen EH, Krusell LR, Kaltoft AK, Maeng M, Terkelsen CJ, Kristensen SD, Lassen JF, Thuesen L. Feasibility and early safety of hybrid coronary revascularisation combining off-pump coronary surgery through J-hemisternotomy with percutaneous coronary intervention. EuroIntervention. 2015 Feb;10(10):e1-6. doi: 10.4244/EIJV10I10A195.
PubMed 24103704
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Hybrid Revascularisation Study Registry on Treatment of Significant Coronary Artery Disease by Combined Bypass Operation (CABG) and Catheter Based Treatment (PCI)
- ClinicalTrials.gov ID
- NCT01496664
- Acronym / sponsor ID
- M-20100152
- Conditions
- Significant Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Study start
- Sep 2010 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 21 Dec 2011 (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.
The purpose of the registry is to assess results of combined operative and catheter based (hybrid procedure) treatment of patients with significant coronary artery disease using essential clinical and angiographic parameters.
Based on existing literature we expect the results of coronary artery bypass grafting of the anterior descendent coronary artery (LAD), segment 1 and 2, using the so-called mammary artery graft, to be superior to stent treatment of the same artery.
At the same time a catheter based intervention using balloon, bare metal stents (BMS) or drug eluting stents (DES) seems to be a better treatment that a saphenous vein graft for other coronary arteries than the LAD. I.e. the right coronary artery (RCA) and the left circumflex coronary artery (CX).
Therefore, we expect a combination of the mentioned surgical and catheter based techniques to be a better treatment than bypass operation or catheter based intervention alone.
Detailed description
A total of 150 consecutive patients will be included in the study. The patients will have a coronary artery narrowing located to the LAD, which can be treated with a mammary graft, and a stenosis located to other coronary arteries (RCA and CX), which can be treated by balloon or stent.
The patients included in the study will be recruited from patients who are referred to the Department of Cardiology/Department of Thoracic Surgery, Aarhus University Hospital, Skejby for treatment of significant coronary artery disease. We will not announce for patients, and the patients will not receive a honorarium for participation.
The first 100 patients will be treated i two seances; operation and stent treatment with few days interval. The last 50 patients will be treated in a hybrid operation room with operation and stent treatment in the same seance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Result of combined CABG and PCI treatment | Experimental | Procedure: Combined CABG and PCIThe registry is to assess results of combined operative and catheter based (hybrid procedure) treatment of patients with significant coronary artery disease using essential clinical and angiographic parameters. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Stable, unstable angina pectoris and ACS.
- Significant stenosis of LAD, segment 1 or 2 and of other coronary arteries.
- The patient can be treated with a mammary graft to LAD and by balloon or stent of other lesions.
- Signed informed consent must be available.
Key exclusion criteria (10 listed)
- Earlier cardiac surgery
- Treatment with coronary stent within one year.
- ST-elevation infarction within 24 hours.
- Coronary artery lesions located to LAD, segment 1 or 2, which cannot be treated by coronary bypass operation.
- Stenosis of diagonal branches, CX artery and the right coronary artery, which cannot be treated by PCI.
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 |
|---|---|---|
| Combined CABG and PCICoronary artery bypass grafting Percutaneous coronary intervention | Procedure or surgery | Result of combined CABG and PCI treatment |
Primary outcome
Combined endpoint of death, stroke, MI and new revascularisation (PCI or CABG) MACCE
Time frame: After 1 year
12 secondary outcomes
Combined endpoint of death, stroke, MI and new revascularisation.
Time frame: After 1 month and after 1, 3 and 5 years
Individual endpoints of death, stroke, MI and new revascularisation.
Time frame: After 1 month and after 1, 3 and 5 years
Death
Time frame: Baseline, 1 month, 1, 2, 3, 4 and 10 years
Procedure related biomarker release
Time frame: Baseline, 1, 3 and 5 year
Reoperation for bleeding
Time frame: Baseline, 1, 3 and 5 year
Operation for suspected sternal infection
Time frame: Baseline, 1, 3 and 5 year
CT verified pulmonary embolism
Time frame: Baseline, 1, 3 and 5 year
CCS angina class
Time frame: 1, 3 and 5 year
NYHA function class
Time frame: 1, 3 and 5 year
Duration of hospitalisation related to the index treatment
Time frame: Baseline
Duration of admission for the index treatment
Time frame: Baseline
Angiographic endpoints
Time frame: 1 year
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 2 Jan 2026.
- Derived from this study: PubMed 30903175Rimestad JM, Christiansen EH, Modrau IS. One-year cost-effectiveness and safety of simultaneous hybrid coronary revascularization versus conventional coronary artery bypass grafting. Interact Cardiovasc Thorac Surg. 2019 Aug 1;29(2):217-223. doi: 10.1093/icvts/ivz083. Epub 2019 Mar 21.
- Derived from this study: PubMed 26432721Modrau IS, Holm NR, Maeng M, Botker HE, Christiansen EH, Kristensen SD, Lassen JF, Thuesen L, Nielsen PH; Hybrid Coronary Revascularization Study Group. One-year clinical and angiographic results of hybrid coronary revascularization. J Thorac Cardiovasc Surg. 2015 Nov;150(5):1181-6. doi: 10.1016/j.jtcvs.2015.08.072. Epub 2015 Aug 28.
- Derived from this study: PubMed 24103704Modrau IS, Nielsen PH, Botker HE, Christiansen EH, Krusell LR, Kaltoft AK, Maeng M, Terkelsen CJ, Kristensen SD, Lassen JF, Thuesen L. Feasibility and early safety of hybrid coronary revascularisation combining off-pump coronary surgery through J-hemisternotomy with percutaneous coronary intervention. EuroIntervention. 2015 Feb;10(10):e1-6. doi: 10.4244/EIJV10I10A195.
- Feasibility and early safety of hybrid coronary revasculatisation combining off-pump coronary surgery through J-hemisternotomy with percutaneous coronary interventionLink provided by the sponsor.
- One year clinical and angiographic results of hybrid coronary revascularisationLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined CABG and PCI in people with Significant Coronary Artery Disease, run by Aarhus University Hospital Skejby 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 10 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 2 Jan 2026. 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?
Combined endpoint of death, stroke, MI and new revascularisation (PCI or CABG) MACCE (time frame: After 1 year). 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 NCT01496664, 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 2 Jan 2026.