The ENDEAVOR II Clinical Trial: The Medtronic Endeavor Drug Eluting Coronary Stent System in Coronary Artery Lesions

NCT00614848 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2011-04-11

No results posted yet for this study

Summary

To demonstrate the safety and efficacy of the Driver Coronary Stent coated with 10 mcg/mm ABT-578 compared to the uncoated Driver Stent for the treatment of single de novo lesions in native coronary arteries 2.25-3.5 mm in diameter.

Conditions

  • Vascular Diseases
  • Ischemia
  • Arteriosclerosis
  • Coronary Artery Disease
  • Arterial Occlusive Diseases
  • Coronary Disease
  • Coronary Arteriosclerosis
  • Heart Diseases
  • Myocardial Ischemia

Interventions

DEVICE

Endeavor drug eluting coronary stent

Zotarolimus coated coronary stent (10ug/mm)

Sponsors & Collaborators

  • Medtronic Vascular

    lead INDUSTRY

Principal Investigators

  • J. Fajadet, MD · Clinique Pasteur, France

  • Richard E Kuntz, MD, MSc · Harvard Medical School, USA

  • W. Wijns, MD, PhD · OLV Hospital, Belgium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2005-01-31
Completion
2009-07-31

Countries

  • France

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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 NCT00614848 on ClinicalTrials.gov