Assessment of the Numen Stent With Evaluation in a Randomized Study

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Assessment of the Numen Stent With Evaluation in a Randomized Study

Conditions
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Lesion

Intervention / Treatment
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* Device: PTCA with stent implantation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Numen<br> | Device: PTCA with stent implantation<br>* Eligible patients will be randomly assigned to the implantation of one (or more) Numen or Vision/Mini Vision stent. Each patient will undergo a 1-month follow-up and a clinical visit at 6 months from the procedure.<br>|
| Active Comparator: Vision/MiniVision<br> | Device: PTCA with stent implantation<br>* Eligible patients will be randomly assigned to the implantation of one (or more) Numen or Vision/Mini Vision stent. Each patient will undergo a 1-month follow-up and a clinical visit at 6 months from the procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of Major Adverse Cardiac Events (MACE), Cerebrovascular Events CVE) and Major Bleedings (according to TIMI classification) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any death, cardiac death, stent related fatal / non fatal MI, TVR |  | 1 month | 
| Any death, cardiac death, stent related fatal / non fatal MI, TVR |  | 6 months | 
| Cardiac death, fatal/non fatal MI |  | In hospital | 
| Procedural success, TLR, TVR, ST |  | In hospital | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment of de novo lesions in native coronary arteries