NCT00299429CompletedNot Applicable
Randomised Comparison of Minimally Invasive Direct Coronary Artery Bypass Grafting and Percutaneous Coronary Intervention With Drug-eluting Stents in Patients With Proximal Stenosis of the Left Anterior Descending Coronary Artery
University of Leipzig1 site in 1 country130 target enrollmentStarted: January 1, 2003Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Major adverse cardiac events
Study Overview
Brief Summary
Percutaneous coronary intervention with a sirolimus-coated stent compared to minimally invasive bypass surgery in patients with isolated proximal left anterior descending coronary arteries in terms of non-inferiority of an end point combining mortality, acute myocardial infarction and rate of reintervention of the target vessel within one year.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Single-vessel disease of the proximal LAD with a stenosis > 50% (multivessel disease only if further coronary vessel stenoses do not require treatment)
- •Patients with angina pectoris (CCS 1-4)
- •Asymptomatic patients if clear signs of ischemia in the segments supplied by the LAD as assessed by bicycle ergometry or treadmill and/or scintigraphically and/or stress echo
- •Patients for whom both methods of treatment are equally possible
- •Consensus between the cardiac surgeon and the cardiologist that both inclusion and
Exclusion Criteria
- •are met in the selected case
- •Informed consent of the patient.
- •Exclusion Criteria:
- •Patients < 18 years
- •Previous coronary artery bypass surgery
- •Concomitant diseases that lead to a greater risk for each of the treatment strategies
- •Significant peripheral arterial occlusive disease
- •Concomitant disease with limited life expectancy (e.g. malignant tumours that have not been curatively treated)
- •Objective follow-up examination not possible due to physical or mental handicap
- •Participation in another study.
- •Angiographical exclusion criteria:
- •Left main stem stenosis
- •Multivessel disease for which surgical or interventional therapy on other vessel areas is required.
- •Diagonal/septal branch > 1.5 mm, which might be compromised by a stent
- •Need for acute intervention (e.g. acute myocardial infarction)
- •Total occlusion of the LAD
Arms & Interventions
MIDCAB Surgery
Active Comparator
MIDCAB Surgery
Intervention: Stenting and minimally invasive bypass surgery (Procedure)
PCI with drug-eluting stent
Experimental
PCI with DES
Intervention: PCI with DES (Procedure)
Outcomes
Primary Outcomes
Major adverse cardiac events
Time Frame: 12 months
Secondary Outcomes
- Perioperative complications(30 days)
- cost-effectiveness(12 months)
- CCS-Classification(12 months)
Investigators
Study Sites (1)
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