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

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.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00766129

Enrollment

Registered

2008-10-03

Start date

2008-02-29

Completion date

2011-12-31

Last updated

2011-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stenosis in Saphenous Vein Graft, Drug Eluting Stent

Keywords

saphenous vein graft, TAXUS stent, Chopin stent

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.

Interventions

DEVICETaxus stent implantation

Patients will be treated with implantation of Taxus stent

DEVICELuc-Chopin stent

Patients will be treated will implantation of Luc-Chopin stent

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Neointima hyperplasia volume by Intravascular Ultrasound	9 months

Secondary

Measure	Time frame
All cause mortality	5 years
Cardiovascular mortality	5 years
Stent thrombosis	5 years
Target lesion revascularization	5 years
Angiographic late loss	9 months

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026