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.

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.

Study Overview

• Status: Unknown
• Conditions: Stenosis in Saphenous Vein Graft, Drug Eluting Stent
• Intervention / Treatment: Device: Taxus stent implantation; Device: Luc-Chopin stent

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 04-628
    • Institute of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: T; Implantation of Taxus stent into saphenous vein graft	Device: Taxus stent implantation; Patients will be treated with implantation of Taxus stent
Experimental: C; Implantation of Luc-Chopin stent into saphenous vein graft	Device: Luc-Chopin stent; Patients will be treated will implantation of Luc-Chopin stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Neointima hyperplasia volume by Intravascular Ultrasound	9 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institute of Cardiology, Warsaw, Poland
• Investigators: Principal Investigator: Adam R Witkowski, MD,PhD, Institute of Cardiology, Warsaw, Poland

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): April 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: October 2, 2008
• First Submitted That Met QC Criteria: October 2, 2008
• First Posted (Estimate): October 3, 2008

Study Record Updates

• Last Update Posted (Estimate): July 6, 2011
• Last Update Submitted That Met QC Criteria: July 4, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: saphenous vein graft, TAXUS stent, Chopin stent
• Other Study ID Numbers: N403 2786 33