Coronary Artery Disease
Conditions
Keywords
Stent, drug-eluting stent, Minimally invasive bypass surgery, left anterior descending
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.
Interventions
PROCEDUREStenting and minimally invasive bypass surgery
PROCEDUREPCI with DES
PCI with DES
Sponsors
Cordis Medizinische Apparate GmbH
University of Leipzig
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Single-vessel disease of the proximal LAD with a stenosis \> 50% (multivessel disease only if further coronary vessel stenoses do not require treatment) 2. Patients with angina pectoris (CCS 1-4) 3. 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 4. Patients for whom both methods of treatment are equally possible 5. Consensus between the cardiac surgeon and the cardiologist that both inclusion and
Exclusion criteria
are met in the selected case 6. Informed consent of the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major adverse cardiac events | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Perioperative complications | 30 days |
| CCS-Classification | 12 months |
| cost-effectiveness | 12 months |
Countries
Germany
Outcome results
None listed