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Completed

NCT Number: NCT01496664

Coronary Hybrid Revascularisation Study

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.

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Key information

Conditions

Significant Coronary Artery Disease

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital, Skejby

Aarhus N, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Combined CABG and PCI

Procedure

Coronary artery bypass grafting Percutaneous coronary intervention

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

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital Skejby

Other

Registry information

Official study title

Coronary Hybrid Revascularisation Study Registry on Treatment of Significant Coronary Artery Disease by Combined Bypass Operation (CABG) and Catheter Based Treatment (PCI)

Important dates

Study start
2010
Primary completion
2015
Study completion
2022
First posted
Dec 21, 2011
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.