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XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)

NCT01178268 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 546

Last updated 2016-08-24

Study results available
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Summary

This is a prospective, randomized, active-controlled, open label, parallel two-arm, multi-center, post-approval study descriptively comparing the XIENCE V EECSS to the CYPHER SELECT PLUS Sirolimus-Eluting Coronary Stent System (SECSS) ("CYPHER SELECT PLUS") during commercial use in China.

Conditions

  • Coronary Occlusion
  • Thrombosis (Stent Thrombosis)
  • Vascular Disease
  • Myocardial Ischemia
  • Coronary Artery Stenosis
  • Coronary Disease
  • Coronary Artery Disease
  • Coronary Restenosis

Interventions

DEVICE

XIENCE V EECSS

Patients who will receive this stent.

DEVICE

CYPHER SELECT PLUS SECSS

Patients who will receive this stent.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Gao Runlin, MD, FACC · Fu Wai Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-10-31
Completion
2014-09-30

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 NCT01178268 on ClinicalTrials.gov