Randomised Comparison of T-stenting Versus Culotte Technique for the Treatment of de Novo Coronary Bifurcation Lesion With Drug-eluting Stents (BBK2)

Inclusion Criteria:

1. Clinical indication for interventional treatment of the bifurcation lesion.
2. There is indication to perform the double stenting as judged by the operator.

3. Bifurcation lesions according to the Medina classification of a native coronary artery with a reference vessel diameter: main branch >2,5 mm; side branch >2,25 mm (the difference between vessel diameter of the main and side branch should be ≤1 mm)

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4. The target lesion (main branch and / or side branch) must be at least 50% diameter stenosis.
5. The target lesion has not been previously treated with any interventional procedure.
6. The target vessel (main branch and side branch) must be feasible for stent implantation (successful passage with the guide wire; successful predilataion with an appropriately sized balloon; no heavy calcification; no diffuse distal disease that might impede run off).
7. Patient has no other treatment planned within 30 days of the procedure.
8. Patient has been informed of the nature of the study and agrees to its provisions and has written informed consent as approved by the Ethics Committee.
9. Patient is willing to comply all required post-procedure follow-up.

Exclusion Criteria:

1. Patient had an acute myocardial infarction (> 3x normal CK ) within 72 hours preceding the index procedure and CK has not returned to normal limits at the time of the procedure.
2. Patient will have a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, prasugrel, stainless steel, sirolimus, everolimus, zotarolimus, biolimus or contrast sensitivity that cannot be adequately pre- medicated.
3. Non successful treatment of other lesion during the same procedure
4. Patient has a platelet count of <100,000 cells/mm³ or >700,000 cells/mm³, a White Blood Cells of <3,000 cells/mm³, or documented or liver disease.
5. Patient has a history of bleeding diathesis or coagulopathy.
6. Patient has suffered a stroke within the past six months.
7. Active peptic ulcer or upper gastrointestinal bleeding within the prior 6 months.
8. Patient has a co-morbidity (i.e. cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, or is associated with limited life- expectancy (less than 2 years).
9. Indication for oral anticoagulation

10. Patient must be excluded from the study if any of these angiographic criteria are met:

    1. The target vessel contains intraluminal thrombus.
    2. The target lesion or vessel shows angiographic evidence of severe calcification.
    3. The patient has undergone previous PCI to the target vessel within 6 months.
    4. Pre treatment of the lesion is done with a technique other than balloon angioplasty.