Assessment of the Numen Stent With Evaluation in a Randomized Study

NCT00790283 | Unknown Phase 2

• 2 other identifiers: IBS/04-20072008-A00111-54
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Lesion

Keywords

Treatment of de novo lesions in native coronary arteries

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of Major Adverse Cardiac Events (MACE), Cerebrovascular Events CVE) and Major Bleedings (according to TIMI classification)

  6 months

Secondary Outcomes (4)

• 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

Study Arms (2)

Numen

EXPERIMENTAL

Device: PTCA with stent implantation

Vision/MiniVision

ACTIVE COMPARATOR

Device: PTCA with stent implantation

Interventions

PTCA with stent implantation 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.

Numen; Vision/MiniVision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• International Biomedical Systems S.p.A.: lead

Study Sites (8)

CHU Cote de Nacre

Caen, 14033, France

ACTIVE NOT RECRUITING

CMC De Parly II

Le Chesnay, 78150, France

ACTIVE NOT RECRUITING

Clinique Valmente

Marseille, 13009, France

ACTIVE NOT RECRUITING

Centre Hospitalier Privé Beauregard

Marseille, 13012, France

RECRUITING

Clinique Vert Coteau

Marseille, 13375, France

ACTIVE NOT RECRUITING

Clinique Turin

Paris, 75006, France

NOT YET RECRUITING

Clinique Alleray-Labrouste

Paris, 75018, France

ACTIVE NOT RECRUITING

Clinique Saint Gatien

Tours, 37042, France

ACTIVE NOT RECRUITING

Study Officials

• Thierry Corcos, MD, FACC

  Clinique Turin, Paris, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thierry Corcos, MD, FACC

CONTACT

+33-(0)1-40-088806

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 12, 2008
• First Posted: November 13, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: February 17, 2009

Record last verified: 2009-02

Locations

FR (8)