Assessment of the Numen Stent With Evaluation in a Randomized Study - Full Text View

Sponsored by:	International Biomedical Systems S.p.A.
Information provided by:	International Biomedical Systems S.p.A.
ClinicalTrials.gov Identifier:	NCT00790283

Purpose

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

Condition	Intervention	Phase
Lesion	Device: PTCA with stent implantation	Phase II Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study
Official Title:	Assessment of the Numen Stent With Evaluation in a Randomized Study

Further study details as provided by International Biomedical Systems S.p.A.:

Primary Outcome Measures:

Cumulative incidence of Major Adverse Cardiac Events (MACE), Cerebrovascular Events CVE) and Major Bleedings (according to TIMI classification) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Any death, cardiac death, stent related fatal / non fatal MI, TVR [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Any death, cardiac death, stent related fatal / non fatal MI, TVR [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Cardiac death, fatal/non fatal MI [ Time Frame: In hospital ] [ Designated as safety issue: No ]
Procedural success, TLR, TVR, ST [ Time Frame: In hospital ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Numen: Experimental	Device: 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.
Vision/MiniVision: Active Comparator	Device: 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.

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790283

Locations

France
Clinique Turin
Paris, France, 75006
CMC De Parly II
Le Chesnay, France, 78150
Clinique Alleray-Labrouste
Paris, France, 75018
Centre Hospitalier Privé Beauregard
Marseille, France, 13012
Clinique Vert Coteau
Marseille Cedex 12, France, 13375
Clinique Valmente
Marseille, France, 13009
Clinique Saint Gatien
Tours Cedex, France, 37042
CHU Cote de Nacre
Caen Cedex, France, 14033

Sponsors and Collaborators

International Biomedical Systems S.p.A.

Investigators

Principal Investigator:

Thierry Corcos, MD, FACC

Clinique Turin, Paris, France

More Information

Responsible Party:	International Biomedical Systems S.p.A. ( Nader Shehata )
Study ID Numbers:	IBS/04-2007, 2008-A00111-54
Study First Received:	November 12, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00790283
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by International Biomedical Systems S.p.A.:

Treatment of de novo lesions in native coronary arteries

ClinicalTrials.gov processed this record on January 16, 2009