Coronary Hybrid Revascularisation Study

Tracking Information
First Submitted Date ICMJE	December 19, 2011
First Posted Date ICMJE	December 21, 2011
Last Update Posted Date	March 22, 2017
Study Start Date ICMJE	September 2010
Estimated Primary Completion Date	October 2018 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 19, 2011)	Combined endpoint of death, stroke, MI and new revascularisation (PCI or CABG) MACCE [ Time Frame: After 1 year ]
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; (submitted: March 12, 2015)	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 ]Presence of significant narrowing or occlusion of mammary or vein graft, or lesions treated with stent or balloon.
Original Secondary Outcome Measures ICMJE; (submitted: December 19, 2011)	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: After 10 years ]; Procedure related biomarker release; Reoperation for bleeding; Operation for suspected sternal infection; CT verified pulmonary embolism; CCS angina class; NYHA function class; Duration of hospitalisation related to the index treatment; Duration of admission for the index treatment; Angiographic endpointsPresence of significant narrowing or occlusion of mammary or vein graft, or lesions treated with stent or balloon.
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.
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 ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Significant Coronary Artery Disease
Intervention ICMJE	Procedure: Combined CABG and PCI; Coronary artery bypass grafting Percutaneous coronary intervention
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.; Intervention: Procedure: Combined CABG and PCI
Publications *	Modrau IS, Holm NR, Mæng M, Bøtker 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.; Modrau IS, Nielsen PH, Bøtker HE, Christiansen EH, Krusell LR, Kaltoft AK, Mæng 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Active, not recruiting
Estimated Enrollment ICMJE; (submitted: December 19, 2011)	2000
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	October 2019
Estimated Primary Completion Date	October 2018 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Senior
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
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
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Evald Hoej Christiansen, Aarhus University Hospital Skejby
Study Sponsor ICMJE	Aarhus University Hospital Skejby
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	Aarhus University Hospital Skejby
Verification Date	March 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP