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SPIRIT II: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System

NCT00180310 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2011-07-20

No results posted yet for this study

Summary

Prospective, randomized, active-control, single blind, parallel two-arm multi-center clinical trial comparing XIENCE V® Everolimus Eluting Coronary Stent System to the approved commercially available active control TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System.

TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System is manufactured by Boston Scientific.

Conditions

Interventions

DEVICE

XIENCE V® Everolimus Eluting Coronary Stent

Drug eluting stent implantation stent in the treatment of coronary artery disease.

DEVICE

TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent

Drug eluting stent implantation stent in the treatment of coronary artery disease

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Patrick Serruys · Erasmus Medical Center, Thoraxcenter, Rotterdam, the Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2007-07-31
Completion
2011-02-28

Countries

  • Austria
  • Belgium
  • Denmark
  • France
  • Germany
  • India
  • Italy
  • Netherlands
  • New Zealand
  • Poland
  • South Africa
  • Spain
  • Switzerland

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 NCT00180310 on ClinicalTrials.gov