COMPETE: A Clinical Evaluation of Chrono Carbostent Carbofilm™ Coated Stent

• Chrono Carbostent Carbofilm™ Coated Coronary Stent (Device)
• Driver Cobalt Alloy Coronary Stent (Device)

Primary outcomes

• in-stent late lumen loss (LLL) [180 days]

Secondary outcomes

• Angiographic binary restenosis (diameter stenosis ≥50%) [180 days]
• Clinical Composite Endpoints: - Cardiac death/ MI - Cardiac death / Target vessel MI / (Clinically indicated) TLR* - All death / MI / all repeat revascularization** *Device oriented composite endpoint **Patient oriented composite endpoint [30 days, 180 days, 1 year]
• Stent Thrombosis [acute, 30 days, 180 days, 1 year]
• Acute success (Device and Procedural success) [acute]

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Patients with clinical evidence of ischemic heart disease;
* No clinical and ECG changes suggestive of ongoing acute infarction;
* De novo lesion > 50% and <100% diameter stenosis (DS) in native coronary vessels TIMI flow of >= 1.
* Reference diameter > 2.5 mm or < 4.0 mm;
* Patients with a maximum of two coronary lesions to be treated with a maximum of 2 study stents;

Exclusion Criteria:

* Lesion length > 30 mm;
* Significant (>50%) stenosis proximal or distal to the target lesions that might impede run off;
* Lesions located in saphenous vein graft;
* Lesions located in unprotected left main;
* Presence of > 40% stenosis in the left main;
* Ostial lesion;
* Lesion located in a bifurcation;
* Target lesion with visible thrombus;
* Chronic total occlusion;
* Treatment of restenotic lesions;
* Previous implantation of a stent (BMS/DES) in the target vessel.

• Flavio Airoldi, Dr, Principal investigator, Multimedica IRCCS, Sesto SG (MI) Italy