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

Stenosis in Saphenous Vein Graft, Drug Eluting Stent Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00766129
• Other study ID #: N403 2786 33
• Status: Active, not recruiting
• Phase: Phase 3
• First received: October 2, 2008
• Last updated: July 4, 2011
• Start date: February 2008
• Est. completion date: December 2011

Study information

• Verified date: July 2011
• Source: Institute of Cardiology, Warsaw, Poland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stenosis in Saphenous Vein Graft, Drug Eluting Stent

Intervention

Device:
• Taxus stent implantation
Patients will be treated with implantation of Taxus stent
• Luc-Chopin stent
Patients will be treated will implantation of Luc-Chopin stent

Locations

Country	Name	City	State
Poland	Institute of Cardiology	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cardiology, Warsaw, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neointima hyperplasia volume by Intravascular Ultrasound		9 months	No
Secondary	All cause mortality		5 years	Yes
Secondary	Cardiovascular mortality		5 years	Yes
Secondary	Stent thrombosis		5 years	Yes
Secondary	Target lesion revascularization		5 years	Yes
Secondary	Angiographic late loss		9 months	No