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Clinical Trials/NCT00388934
NCT00388934CompletedPhase 4

Randomized Clinical Comparison of Cypher Select and Taxus Express Stent Implantation in Unselected Patients With Coronary Artery Disease.

Aarhus University Hospital Skejby0 sites2,095 target enrollmentStarted: August 1, 2004Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
2,095
Primary Endpoint
MACE (cardiac death, myocardial infarction, target vessel revascularisation, target lesion revascularisation, TVF)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Randomized nine months clinical comparison of implantation of Taxol eluting (Taxus Express) and Sirolimus eluting (Cypher Select) stents in non-selected patients with coronary artery disease.

Detailed Description

Design:

  • Randomized open multicentre trial.

Patients:

  • 1800 patients with coronary artery disease scheduled for percutaneous coronary intervention with stent implantation.

Inclusion criteria:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Planned implantation of drug eluting stent
  • •Written informed consent

Exclusion Criteria

  • •Planned intervention with other stents than study stents

Outcomes

Primary Outcomes

MACE (cardiac death, myocardial infarction, target vessel revascularisation, target lesion revascularisation, TVF)

Time Frame: during 9 months

Secondary Outcomes

  • Total death(after 9 months, 2 and 3 years)
  • Cardiac death(after 9 months, 2 and 3 years)
  • Myocardial infarction(after 9 months, 2 and 3 years)
  • Target vessel revascularisation, target lesion revascularisation, TVF(after 9 months, 2 and 3 years)
  • Stent thrombosis(after 9 months, 2 and 3 years)

Investigators

Sponsor
Aarhus University Hospital Skejby
Sponsor Class
Other

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