Coronary Hybrid Revascularisation Study

December 29, 2025 updated by: Evald Hoej Christiansen, Aarhus University Hospital Skejby

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • Aarhus University Hospital, Skejby

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Coronary artery bypass grafting Percutaneous coronary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Combined endpoint of death, stroke, MI and new revascularisation (PCI or CABG) MACCE
Time Frame: After 1 year
After 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Combined endpoint of death, stroke, MI and new revascularisation.
Time Frame: After 1 month and after 1, 3 and 5 years
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
After 1 month and after 1, 3 and 5 years
Death
Time Frame: Baseline, 1 month, 1, 2, 3, 4 and 10 years
Baseline, 1 month, 1, 2, 3, 4 and 10 years
Procedure related biomarker release
Time Frame: Baseline, 1, 3 and 5 year
Baseline, 1, 3 and 5 year
Reoperation for bleeding
Time Frame: Baseline, 1, 3 and 5 year
Baseline, 1, 3 and 5 year
Operation for suspected sternal infection
Time Frame: Baseline, 1, 3 and 5 year
Baseline, 1, 3 and 5 year
CT verified pulmonary embolism
Time Frame: Baseline, 1, 3 and 5 year
Baseline, 1, 3 and 5 year
CCS angina class
Time Frame: 1, 3 and 5 year
1, 3 and 5 year
NYHA function class
Time Frame: 1, 3 and 5 year
1, 3 and 5 year
Duration of hospitalisation related to the index treatment
Time Frame: Baseline
Baseline
Duration of admission for the index treatment
Time Frame: Baseline
Baseline
Angiographic endpoints
Time Frame: 1 year
Presence of significant narrowing or occlusion of mammary or vein graft, or lesions treated with stent or balloon.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital Skejby

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2010

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

December 19, 2011

First Submitted That Met QC Criteria

December 19, 2011

First Posted (Estimated)

December 21, 2011

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-20100152

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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