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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by Institute of Cardiology, Warsaw, Poland.
Recruitment status was:  Active, not recruiting
Information provided by:
Institute of Cardiology, Warsaw, Poland Identifier:
First received: October 2, 2008
Last updated: July 4, 2011
Last verified: July 2011
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 Intervention Phase
Stenosis in Saphenous Vein Graft, Drug Eluting Stent Device: Taxus stent implantation Device: Luc-Chopin stent Phase 3

Study Type: Interventional
Study Design: 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.

Further study details as provided by Institute of Cardiology, Warsaw, Poland:

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

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

Estimated Enrollment: 50
Study Start Date: February 2008
Estimated Study Completion Date: December 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Adam Witkowski, Institute of Cardiology,Warsaw,Poland Identifier: NCT00766129     History of Changes
Other Study ID Numbers: N403 2786 33
Study First Received: October 2, 2008
Last Updated: July 4, 2011

Keywords provided by Institute of Cardiology, Warsaw, Poland:
saphenous vein graft, TAXUS stent, Chopin stent processed this record on September 21, 2017