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CompletedNCT01496664Updated Jan 2, 2026

Coronary Hybrid Revascularisation Study

An interventional study of Combined CABG and PCI in Significant Coronary Artery Disease, sponsored by Aarhus University Hospital Skejby. Completed at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2026-01-02.

Sponsored by Aarhus University Hospital Skejby · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Sep 2010, registered Dec 2011).
Phase
Not applicable
Study type
Interventional
Enrollment
2,000
Allocation
Not applicable
Sex
All
01

Study 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.

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.

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.

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Conditions studied

  • Significant Coronary Artery Disease
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In context

Lead sponsor

Aarhus University Hospital Skejby is the lead sponsor of 59 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2,000 participants (estimated)

Study arms

  • Experimental
    Result of combined CABG and PCI treatment

    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.

    Procedure: Combined CABG and PCI

Interventions

  • ProcedureCombined CABG and PCI

    Coronary artery bypass grafting Percutaneous coronary intervention

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What researchers measure

Primary outcomes

  1. Combined endpoint of death, stroke, MI and new revascularisation (PCI or CABG) MACCE

    Time frame: After 1 year

Secondary outcomes

  1. Combined endpoint of death, stroke, MI and new revascularisation.

    Time frame: After 1 month and after 1, 3 and 5 years

  2. Individual endpoints of death, stroke, MI and new revascularisation.

    Time frame: After 1 month and after 1, 3 and 5 years

  3. Death

    Time frame: Baseline, 1 month, 1, 2, 3, 4 and 10 years

  4. Procedure related biomarker release

    Time frame: Baseline, 1, 3 and 5 year

  5. Reoperation for bleeding

    Time frame: Baseline, 1, 3 and 5 year

  6. Operation for suspected sternal infection

    Time frame: Baseline, 1, 3 and 5 year

  7. CT verified pulmonary embolism

    Time frame: Baseline, 1, 3 and 5 year

  8. CCS angina class

    Time frame: 1, 3 and 5 year

  9. NYHA function class

    Time frame: 1, 3 and 5 year

  10. Duration of hospitalisation related to the index treatment

    Time frame: Baseline

  11. Duration of admission for the index treatment

    Time frame: Baseline

  12. Angiographic endpoints

    Presence of significant narrowing or occlusion of mammary or vein graft, or lesions treated with stent or balloon.

    Time frame: 1 year

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Study locations

1 site
  • Aarhus University Hospital, Skejby
    Aarhus N, 8200, Denmark
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References and documents

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 30903175 ↗
  • Modrau 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 26432721 ↗
  • Modrau 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01496664
Lead sponsor
Aarhus University Hospital Skejby
Responsible party
Evald Hoej Christiansen (MD, phd, Aarhus University Hospital Skejby) — Principal investigator
First posted
Dec 21, 2011
Start date
Sep 2010
Primary completion
Sep 2015
Completion
Dec 2022
Last update
Jan 2, 2026

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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