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

National Institute of Cardiology, Warsaw, Poland

Status and phase: Unknown; Phase 3

Conditions: Stenosis in Saphenous Vein Graft, Drug Eluting Stent

Treatments: Device: Taxus stent implantation; Device: Luc-Chopin stent

Study type: Interventional

Funder types: Other

Identifiers

NCT00766129

N403 2786 33

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

T

Experimental group

Description:

Implantation of Taxus stent into saphenous vein graft

Treatment:

Device: Taxus stent implantation

C

Experimental group

Description:

Implantation of Luc-Chopin stent into saphenous vein graft

Treatment:

Device: Luc-Chopin stent