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CYPRESS

CYPRESS

Objective

Status

Enrollment complete

Condition

Coronary Artery Disease

Description

A Prospective, Randomized, Multi-Center, Double-Blind Trial to Assess the Effectiveness and Safety of Different Durations of Dual Anti-Platelet Therapy (DAPT) in Persons Undergoing Percutaneous Coronary Intervention With the CYPHER® Sirolimus-eluting Coronary Stent (CYPHER® Stent

Purpose

To assess the rate of target lesion failure in persons implanted with the CYPHER® stent and receiving dual antiplatelet therapy for 12 months

Phase

IV

Key Inclusion Criteria

  • 18 years of age or older
  • Persons undergoing percutaneous intervention with stent deployment
  • Persons without known contraindication to dual antiplatelet therapy for at least 30 months after enrollment and stent implantation

Key Exclusion Criteria

  • Index procedure requiring use of a stent with a nominal diameter < 2.25 mm or > 3.5 mm
  • Pregnant women
  • Planned (at time of enrollment) surgery necessitating discontinuation of antiplatelet therapy within the 30 months following enrollment
  • Current medical condition with a life expectancy of less than 3 years
  • Concurrent enrollment in another device or drug study where the primary endpoint has not been reached or the device/drug might affect major endpoint outcomes in either Phase I or Phase II of the study
  • The person may only be enrolled in the study once
  • Persons on warfarin or similar anticoagulant therapy
  • Persons with hypersensitivity or allergies to one of the drugs or components indicated in the instructions for use for the device implanted
  • Persons unable to give informed consent
  • Persons treated with both drug eluting stent (DES) and bare metal stent (BMS) during the index procedure

ClinicalTrials.gov Identifier

NCT00954707

IRB Protocol Number
P09 6301
Principal Investigator(s)
Rabeea Aboufakher, MD

Clinical Trial Categories

  • Interventional Cardiology
Sponsor(s)
Cordis Corporation
Contact
Brenda Westacott, CCRC at 701-780-1845
or bwestacott@altru.org