This trial is active, not recruiting.

Condition stenosis in saphenous vein graft, drug eluting stent
Treatments taxus stent implantation, luc-chopin stent
Phase phase 3
Sponsor Institute of Cardiology, Warsaw, Poland
Start date February 2008
End date April 2011
Trial size 50 participants
Trial identifier NCT00766129, N403 2786 33


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Implantation of Taxus stent into saphenous vein graft
taxus stent implantation
Patients will be treated with implantation of Taxus stent
Implantation of Luc-Chopin stent into saphenous vein graft
luc-chopin stent
Patients will be treated will implantation of Luc-Chopin stent

Primary Outcomes

Neointima hyperplasia volume by Intravascular Ultrasound
time frame: 9 months

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

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.
Principal investigator Adam R Witkowski, MD,PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2011.
Information provided to ClinicalTrials.gov by Institute of Cardiology, Warsaw, Poland.