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Assessment of the Numen Stent With Evaluation in a Randomized Study

NCT00790283 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2009-02-17

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • International Biomedical Systems S.p.A.

    lead INDUSTRY

Principal Investigators

  • Thierry Corcos, MD, FACC · Clinique Turin, Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00790283 on ClinicalTrials.gov