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Comparison of Safety and Efficacy of Two Different Drug Eluting Stents Implanted Into Saphenous Vein Grafts

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ClinicalTrials.gov Identifier: NCT00766129
Recruitment Status : Unknown
Verified July 2011 by Institute of Cardiology, Warsaw, Poland.
Recruitment status was:  Active, not recruiting
First Posted : October 3, 2008
Last Update Posted : July 6, 2011
Information provided by:
Institute of Cardiology, Warsaw, Poland

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.

Condition or disease Intervention/treatment Phase
Stenosis in Saphenous Vein Graft, Drug Eluting Stent Device: Taxus stent implantation Device: Luc-Chopin stent Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : February 2008
Primary Completion Date : April 2011
Estimated Study Completion Date : December 2011

Arm Intervention/treatment
Experimental: T
Implantation of Taxus stent into saphenous vein graft
Device: Taxus stent implantation
Patients will be treated with implantation of Taxus stent
Experimental: C
Implantation of Luc-Chopin stent into saphenous vein graft
Device: Luc-Chopin stent
Patients will be treated will implantation of Luc-Chopin stent

Primary Outcome Measures :
  1. Neointima hyperplasia volume by Intravascular Ultrasound [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: 5 years ]
  2. Cardiovascular mortality [ Time Frame: 5 years ]
  3. Stent thrombosis [ Time Frame: 5 years ]
  4. Target lesion revascularization [ Time Frame: 5 years ]
  5. Angiographic late loss [ Time Frame: 9 months ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00766129

Institute of Cardiology
Warsaw, Poland, 04-628
Sponsors and Collaborators
Institute of Cardiology, Warsaw, Poland
Principal Investigator: Adam R Witkowski, MD,PhD Institute of Cardiology, Warsaw, Poland

Responsible Party: Adam Witkowski, Institute of Cardiology,Warsaw,Poland
ClinicalTrials.gov Identifier: NCT00766129     History of Changes
Other Study ID Numbers: N403 2786 33
First Posted: October 3, 2008    Key Record Dates
Last Update Posted: July 6, 2011
Last Verified: July 2011

Keywords provided by Institute of Cardiology, Warsaw, Poland:
saphenous vein graft, TAXUS stent, Chopin stent