Assessment of the Numen Stent With Evaluation in a Randomized Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-09-30

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

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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.

Conditions

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Lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Numen

Group Type EXPERIMENTAL

PTCA with stent implantation

Intervention Type DEVICE

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.

Vision/MiniVision

Group Type ACTIVE_COMPARATOR

PTCA with stent implantation

Intervention Type DEVICE

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.

Interventions

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PTCA with stent implantation

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.

Intervention Type DEVICE

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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International Biomedical Systems S.p.A.

Principal Investigators

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Thierry Corcos, MD, FACC

Role: PRINCIPAL_INVESTIGATOR

Clinique Turin, Paris, France

Locations

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