MedTrace Logo

XIENCE V: SPIRIT WOMEN Sub-study

NCT01182428 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 455

Last updated 2012-08-07

Study results available
· View outcomes & findings →

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

DEVICE

CYPHER SELECT

XIENCE V® / XIENCE PRIME™ to CYPHER SELECT in female patients with de novo coronary artery lesions

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
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2011-02-28
Completion
2011-07-31

Countries

  • Argentina
  • Austria
  • Belgium
  • Brazil
  • Denmark
  • France
  • Germany
  • Hungary
  • Italy
  • Latvia
  • Netherlands
  • Norway
  • Poland
  • 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 NCT01182428 on ClinicalTrials.gov