MedTrace Logo

Safety and Efficacy Study of the Nile PAX Drug-Eluting Coronary Bifurcation Stent

NCT01308229 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2015-04-08

No results posted yet for this study

Summary

The purpose of this trial is to assess the safety and efficacy of the Nile PAX® Drug Eluting Coronary Bifurcation Stent System for the treatment of single de novo bifurcation lesions in native coronary arteries with a main branch reference vessel diameter of 2.5-3.5 mm and side branch reference vessel diameter of 2.0-3.0 mm.

Conditions

  • Coronary Disease

Interventions

DEVICE

Nile PAX® paclitaxel-eluting coronary stent

Implantation of a Nile PAX bifurcation dedicated drug-eluting stent in coronary arteries to treat stenosis lesions

Sponsors & Collaborators

  • MINVASYS

    lead INDUSTRY

Principal Investigators

  • Jean FAJADET, MD · Clinique Pasteur Toulouse

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
2008-12-31
Primary Completion
2011-01-31
Completion
2015-03-31

Countries

  • Brazil
  • Bulgaria
  • France
  • Italy
  • Netherlands
  • Poland
  • Spain

Study Locations

More Related Trials

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 NCT01308229 on ClinicalTrials.gov