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Numen Stent Assessment Using OCT Technique in a Single Center Study

NCT00774917 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2009-06-23

No results posted yet for this study

Summary

This is a prospective single centre Study designed to assess by OCT the effect of NUMEN cobalt-chromium balloon-expandable stent in inducing neointimal hyperplasia in de novo native coronary lesions of patients with Stable Angina Pectoris or ACS (except STEMI).

A total of 60 consecutive patients will be enrolled in the study. Patients with de novo native coronary artery lesions \>10mm and \<24mm in length and \>2.50mm to \<3.50mm in diameter by QCA estimate who meet all eligibility criteria will be enrolled and undergone stent implantation. After stent deployment an OCT imaging will be performed within the treated segment. Patients will be followed at 30 days, 6 months and 12 months post-procedure, with all patients having repeat angiography and OCT at 6 months.

It is anticipated that the total length of the study will be 18 months: 6 months to complete patient enrolment and 12 months for follow-up.

Conditions

  • Hyperplasia
  • Restenosis

Interventions

DEVICE

Numen

Numen Co-Cr coronary stent implant

Sponsors & Collaborators

  • CSC Pharmaceuticals

    collaborator INDUSTRY

  • International Biomedical Systems S.p.A.

    lead INDUSTRY

Principal Investigators

  • Helmut Dietmar Glogar, Prof. · University Hospital of Vienna

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-09-30
Completion
2010-03-31

Countries

  • Austria

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 NCT00774917 on ClinicalTrials.gov