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

Phase 3

• Conditions: Stenosis in Saphenous Vein Graft, Drug Eluting Stent
• Interventions: Device: Taxus stent implantation; Device: Luc-Chopin stent

• Registration Number: NCT00766129
• Lead Sponsor: National 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-10-02
• Study First Submitted QC: 2008-10-02
• Study First Posted: 2008-10-03
• Primary Completion: 2011-04
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-04
• Last Update Posted: 2011-07-06
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T	Taxus stent implantation	Implantation of Taxus stent into saphenous vein graft
C	Luc-Chopin stent	Implantation of Luc-Chopin stent into saphenous vein graft

Primary Outcome Measures

Name	Time	Method
Neointima hyperplasia volume by Intravascular Ultrasound	9 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institute of Cardiology; 🇵🇱 Warsaw, Poland