Assessment of the Numen Stent With Evaluation in a Randomized Study (ANSWERS)

International Biomedical Systems

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Lesion

Treatments

Device: PTCA with stent implantation

Study type

Interventional

Funder types

Industry

Identifiers

NCT00790283

IBS/04-2007

2008-A00111-54

Details and patient eligibility

About

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

Full description

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.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)