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Clinical Trials/NCT00766129
NCT00766129
Unknown
Phase 3

Comparison of Safety and Efficacy of Drug Eluting Stents : TAXUS (Boston Scientific) vs. LUC-Chopin (Balton, Poland) Implanted Into Saphenous Vein Grafts. Study With Serial Intravascular Ultrasounds.

National Institute of Cardiology, Warsaw, Poland1 site in 1 country50 target enrollmentFebruary 2008

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Stenosis in Saphenous Vein Graft, Drug Eluting Stent
Sponsor
National Institute of Cardiology, Warsaw, Poland
Enrollment
50
Locations
1
Primary Endpoint
Neointima hyperplasia volume by Intravascular Ultrasound
Last Updated
14 years ago

Overview

Brief Summary

Drug eluting stents significantly reduced the rate of in-stent restenosis in coronary arteries. There are several kinds of DES i.e. eluting the drug either from stable or biodegradable polymer. The type of the polymer may impact the clinical outcome. The aim of our study was to compare safety and efficacy of implantation of two different types of stents eluting paclitaxel from stable vs biodegradable polymer (TAXUS stent vs LUC-CHOPIN stent) into coronary artery by-pass graft.

Registry
clinicaltrials.gov
Start Date
February 2008
End Date
December 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
National Institute of Cardiology, Warsaw, Poland

Eligibility Criteria

Inclusion Criteria

  • Atherosclerotic lesion in saphenous vein grafts causing angiographic stenosis ≥70%
  • Stable coronary artery disease or non ST segment elevation acute coronary syndrome
  • Reference segment diameter in range of 2.5-4.5mm

Exclusion Criteria

  • Cardiogenic shock
  • Contraindications to prolonged dual antiplatelet therapy
  • Female of child birth potential unless on effective contraception
  • Other medical condition that may limit survival

Outcomes

Primary Outcomes

Neointima hyperplasia volume by Intravascular Ultrasound

Time Frame: 9 months

Secondary Outcomes

  • All cause mortality(5 years)
  • Cardiovascular mortality(5 years)
  • Target lesion revascularization(5 years)
  • Angiographic late loss(9 months)
  • Stent thrombosis(5 years)

Study Sites (1)

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