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Prospective, Randomized, Multicenter Trial to Assess PROMUS™ Element™ Stent

NCT01285999 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2025-03-11

Study results available
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Summary

The purpose of this study is to evaluate the safety and effectiveness of the PROMUS™ Element™ Everolimus-Eluting Coronary Stent System for the treatment of subjects in China with a single de novo atherosclerotic coronary artery lesion.

Conditions

Interventions

DEVICE

PROMUS Element Coronary Stent System

Everolimus-eluting Coronary Stent Drug-eluting Stent (DES) implantation

DEVICE

TAXUS Liberté Coronary Stent System

Paclitaxel-eluting Coronary Stent Drug-eluting Stent (DES) implantation

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Yuejin Yang · Cardiovascular Institute and Fu Wai Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-03-31
Completion
2014-08-31

Countries

  • China

Study Locations

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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 NCT01285999 on ClinicalTrials.gov