Angiography Versus (vs) IVUS Optimisation

Angiography vs. IVUS Optimisation: A Multi-Centre European Study of Drug Eluting Stent Implantation

The purpose of the study id to demonstrate an advantage for intra-vascular ultrasound (IVUS) optimized drug-eluting stent (DES) implantation compared to angiography in complex lesions

Inclusion Criteria:

• A complex lesion is regarded as a lesion where the operator would expect a lower immediate and long term success rate compared to non-complex lesions (according to the results of Randomized Controlled Trials and from large Registries). The operator must consider the implantation of a drug-eluting stent, feasible and appropriate for this particular complex lesion

Exclusion Criteria:

• Contra-indication to dual anti-platelet therapy.
• Ejection fraction <30%.
• Renal failure (creatinine >2 mg/dL).
• Significant co-morbidity precluding clinical follow-up.
• Acute myocardial infarction in the 48 hours prior to the procedure.
• In-stent restenosis
• Prior brachytherapy
• Thrombocytopenia <100,000
• Unprotected left main stem stenosis
• Venous or arterial grafts
• Recipient of heart transplant
• A positive pregnancy test in women with child bearing potential
• Acute infections
• Major surgery planned which will lead to discontinuation of antiplatelet therapy
• Patients with prior BMS or DES implanted in the target vessel less than one year prior to the enrollment, including one year from any intercurrent restenotic or thrombotic event
• Age under 18 years old.
• There is no maximum number of lesions which can be treated