Coronary Hybrid Revascularisation Study
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 19, 2011 | ||||||||
| Last Updated Date | June 24, 2014 | ||||||||
| Start Date ICMJE | September 2010 | ||||||||
| Estimated Primary Completion Date | October 2018 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Combined endpoint of death, stroke, MI and new revascularisation (PCI or CABG) MACCE [ Time Frame: After 1 year ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01496664 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Coronary Hybrid Revascularisation Study | ||||||||
| Official Title ICMJE | Coronary Hybrid Revascularisation Study Registry on Treatment of Significant Coronary Artery Disease by Combined Bypass Operation (CABG) and Catheter Based Treatment (PCI) | ||||||||
| Brief 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. |
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| 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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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Significant Coronary Artery Disease | ||||||||
| Intervention ICMJE | Procedure: Combined CABG and PCI
Coronary artery bypass grafting Percutaneous coronary intervention |
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| Study Arm (s) | 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.
Intervention: Procedure: Combined CABG and PCI |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 2000 | ||||||||
| Estimated Completion Date | October 2019 | ||||||||
| Estimated Primary Completion Date | October 2018 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Denmark | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01496664 | ||||||||
| Other Study ID Numbers ICMJE | M-20100152 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Jens Flensted Lassen, Aarhus University Hospital Skejby | ||||||||
| Study Sponsor ICMJE | Aarhus University Hospital Skejby | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Aarhus University Hospital Skejby | ||||||||
| Verification Date | June 2014 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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