The Medtronic RESOLUTE US Clinical Trial

NCT00726453 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1516

Last updated 2016-05-23

Study results available
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Summary

The objective of the study is to assess the safety and effectiveness of the Resolute Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm.

Conditions

Interventions

DEVICE

Resolute Zotarolimus-Eluting Coronary Stent

Implantation of a Resolute Zotarolimus-Eluting Coronary Stent

Sponsors & Collaborators

  • Medtronic Vascular

    lead INDUSTRY

Principal Investigators

  • Martin B Leon, MD · Columbia University College of Physicians & Surgeons

  • Laura Mauri, MD, MSc · Brigham and Women's Hospital

  • Alex C Yeung, MD · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2011-01-31
Completion
2016-03-31

Countries

  • United States

Study Locations

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Entities

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 NCT00726453 on ClinicalTrials.gov