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A Registry To Evaluate Safety And Effectiveness Of Everolimus Drug Eluting Stent For Coronary Revascularization

NCT01157455 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1900

Last updated 2010-07-12

No results posted yet for this study

Summary

This is a prospective, multi-center registry to evaluate safety and effectiveness of the Everolimus Drug Eluting Stent for treatment coronary revascularization in Chinese patients with long lesion, small vessel or multi-vessel diseases.

Conditions

  • Coronary Artery Diseases

Interventions

PROCEDURE

Everolimus Drug Eluting Stent

Implantation

DRUG

Aspirin

Orally take by 300mg per day at least within 24 hours before index procedure. Orally 100mg indefinitely after the procedure as a part of dual anti-platelet therapy

DRUG

Clopidogrel

A loading dose of 300mg must be given at least 6 hours prior to index procedure, or a loading dose of 75mg/d 72 hours prior to index procedure. 75mg daily for at least 12 months after the procedure as a part of dual anti-platelet therapy.

DRUG

Heparin or Bivalirudin

During procedure or in-hospital, Heparin 100u/kg or Bivalirudin may be given,or follow up the standard practice of each site.

Sponsors & Collaborators

  • CCRF Consulting Co., Ltd.

    lead OTHER

Principal Investigators

  • Yuejin Yang · Chinese Academy of Medical Sciences, Fuwai Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-03-31
Completion
2013-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT01157455 on ClinicalTrials.gov