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XIENCE V: SPIRIT WOMEN

NCT00496938 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1600

Last updated 2015-05-13

No results posted yet for this study

Summary

The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female patients with de novo coronary artery lesions, and the characterization of the female population undergoing stent implantation with a XIENCE stent.

Conditions

  • Coronary Artery Stenosis
  • Coronary Arteriosclerosis
  • Coronary Artery Disease
  • Coronary Artery Restenosis
  • Total Coronary Occlusion
  • Stent Thrombosis
  • Vascular Disease
  • Myocardial Ischemia

Interventions

DEVICE

XIENCE V®/ XIENCE PRIME™

Coronary artery placement of a XIENCE V®/ XIENCE PRIME™ Everolimus Eluting Stent System

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Marie-Claude Morice · Institut Cardiovasculaire Paris Sud (ICPS), Paris, France

  • Stephan Windecker · University Hospital Bern, Bern, Switzerland

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2010-08-31
Completion
2011-07-31

Countries

  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • China
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • India
  • Israel
  • Italy
  • Latvia
  • Malaysia
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • South Africa
  • Spain
  • Switzerland
  • United Kingdom
  • Venezuela

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 NCT00496938 on ClinicalTrials.gov