SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions (Diabetic Sub-Study)

NCT01171820 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2016-06-27

Study results available
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Summary

The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery lesions in patients (Diabetic sub-study).

Conditions

Interventions

DEVICE

TAXUS® Liberté™

Drug eluting stent implantation stent in the treatment of coronary artery disease in participants with Diabetes

DEVICE

XIENCE V® EECSS

Drug eluting stent implantation stent in the treatment of coronary artery disease in participants with Diabetes

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Eberhard Grube, MD · International Heart Center Rhein-Ruhr, Essen, Germany

  • Upendra Kaul, MD · Fortis Hospital, New Delhi, India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2009-07-31
Completion
2010-07-31

Countries

  • Austria
  • France
  • Germany
  • Israel
  • Italy
  • Malaysia
  • Netherlands
  • Poland
  • Spain
  • Thailand
  • United Kingdom

Study Locations

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Entities

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 NCT01171820 on ClinicalTrials.gov