Assessment of the Numen Stent With Evaluation in a Randomized Study

Assessment of the Numen Stent With Evaluation in a Randomized Study

The purpose of this study is to Evaluate the Short-Term and Mid-Term Safety and Efficacy of the NUMEN Cobalt-Chromium coronary stent for the treatment of de novo lesions in native coronary arteries and compare it to the VISION/MINIVISION coronary stent

The success of bare metal coronary stenting is limited by the restenosis phenomenon, with rates depending on patient vascular morphology and lesion-related factors, the indication for and technique of stent deployment, and others. Drug-eluting stents (DES) improve the treatment of many coronary artery lesions by significantly reducing in-stent restenosis. However, there have numerous limitations resulting from the need for long-term dual antiplatelet therapy, the consequent bleeding risk (old patients, surgery, colon or gastric cancer, trauma), the unknown side-effects of long-term antiplatelet therapy, the cost associated with a long-term thienopyridine regimen, the body's reaction to the stent polymer, and the 0.2% per year increase in late stent thrombosis in comparison with bare metal stents (BMS).

For these reasons, continuous research is devoted to improve the effectiveness of bare metal stents. The ideal stent should be non-thrombogenic, with a low rate of restenosis and late thrombotic events. The NUMEN stent has been designed to meet these criteria, using an extremely low stent strut thickness.

Inclusion Criteria:

• Age > 18 years
• Clinical or instrumental documentation of stable/unstable myocardial ischemia or angina with a >50% lesion on a major coronary vessel and/or side branch > 2.0 mm
• Lesion length ≤ 20 mm
• Vessel requiring stent size with diameter ≥ 2.5 mm

Exclusion Criteria:

• Age < 18 years
• Life expectancy < 6 months
• Chronic renal failure (serum creatinine > 2 mg %)
• Ongoing acute myocardial infarction
• Left ventricular ejection fraction (LVEF) <30%
• Cardiogenic shock
• Documented or suspected systemic and/or infectious disease
• Hypersensitivity to cobalt chromium or contrast media
• Anti-thrombotic drug intolerance
• Cardiac and/or extracardiac documented disease requiring surgical repair
• Patient is not an acceptable candidate for emergent coronary artery bypass surgery
• Primary or secondary pulmonary hypertension (by echo-doppler)
• Planned > 2 stent implantation (except bail-out)
• Recent (< 6 months) PCI or CABG
• Other type of stent implantation (also in case of bail-out)
• Visible endocoronary thrombosis
• Diffuse, severe coronary calcifications
• Use of debulking devices
• Extreme vessel tortuosity
• Unprotected left main stenosis (ULM)
• Bifurcation lesion
• In stent restenosis (ISR)
• Saphenous vein graft (SVG) and arterial by pass (internal mammary artery,IMA)
• Chronic total occlusion (CTO)