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Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth

NCT00349895 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-04-08

No results posted yet for this study

Summary

This is a multi-center, prospective, non-randomized study. Approximately 90 patients from up to 16 centers will be entered in the study. Patients will be followed clinically for up to 5 years post-procedure. All patients will have a repeat angiography at 6 months follow-up.

The primary objective of this study is to evaluate the safety and effectiveness of the Genous Bio-engineered R stentTM in conjunction with optimal statin therapy (80mg of atorvastatin), in the treatment of elective patients with up to two de novo native coronary artery lesions. The Genous stent received CE mark for the intended indication in August 2005

Conditions

Interventions

DEVICE

Coronary stent implantation

Percutaneous Coronary Intervention

Sponsors & Collaborators

  • OrbusNeich

    lead INDUSTRY

Principal Investigators

  • Patrick W Serruys, MD, PhD · Erasmus Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2008-01-31
Completion
2012-01-31

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT00349895 on ClinicalTrials.gov