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

NCT ID: NCT00766129

Last Updated: 2011-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2011-12-31

Brief Summary

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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

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Conditions

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Stenosis in Saphenous Vein Graft, Drug Eluting Stent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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T

Implantation of Taxus stent into saphenous vein graft

Group Type EXPERIMENTAL

Taxus stent implantation

Intervention Type DEVICE

Patients will be treated with implantation of Taxus stent

C

Implantation of Luc-Chopin stent into saphenous vein graft

Group Type EXPERIMENTAL

Luc-Chopin stent

Intervention Type DEVICE

Patients will be treated will implantation of Luc-Chopin stent

Interventions

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Taxus stent implantation

Patients will be treated with implantation of Taxus stent

Intervention Type DEVICE

Luc-Chopin stent

Patients will be treated will implantation of Luc-Chopin stent

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Cardiology, Warsaw, Poland

OTHER

Sponsor Role lead

Responsible Party

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Institute of Cardiology,Warsaw,Poland

Principal Investigators

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Adam R Witkowski, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Cardiology, Warsaw, Poland

Locations

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Institute of Cardiology

Warsaw, , Poland

Site Status

Countries

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Poland

Other Identifiers

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N403 2786 33

Identifier Type: -

Identifier Source: org_study_id

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