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RESOLUTE China RCT

NCT01334268 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2017-10-18

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the in-stent late lumen loss (LLL) at 9 months, defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up angiography MLD, of the Resolute Zotarolimus-Eluting Coronary Stent System compared to Taxus Liberte Paclitaxel-Eluting Coronary Stent System in a real-world all-comer patient population requiring stent implantation.

Conditions

Interventions

DEVICE

Taxus Liberte Paclitaxel-Eluting Coronary Stent System

Taxus Liberte Paclitaxel-Eluting Coronary Stent System Implantation

DEVICE

Resolute Zotarolimus-Eluting Coronary Stent System

Resolute Zotarolimus-Eluting Coronary Stent System Implantation

Sponsors & Collaborators

  • Medtronic Vascular

    lead INDUSTRY

Principal Investigators

  • Shuzheng Lv · An Zhen Hospital

  • Yundai Chen · Chinese PLA General Hospital

  • Zhimin Du · First Affiliated Hospital, Sun Yat-Sen University

  • Bo Xu · Beijing Fu Wai Hospital

  • Yuejin Yang, MD · Fu Wai Hospital, Beijing, China

  • Zuyi Yuan · First Affiliated Hospital of Medical College of ZI'AN Jiaotong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-11-30
Completion
2017-06-30

Countries

  • China

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 NCT01334268 on ClinicalTrials.gov