NCT00766129
Unknown
Phase 3
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.
National Institute of Cardiology, Warsaw, Poland1 site in 1 country50 target enrollmentFebruary 2008
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Stenosis in Saphenous Vein Graft, Drug Eluting Stent
- Sponsor
- National Institute of Cardiology, Warsaw, Poland
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Neointima hyperplasia volume by Intravascular Ultrasound
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Atherosclerotic lesion in saphenous vein grafts causing angiographic stenosis ≥70%
- •Stable coronary artery disease or non ST segment elevation acute coronary syndrome
- •Reference segment diameter in range of 2.5-4.5mm
Exclusion Criteria
- •Cardiogenic shock
- •Contraindications to prolonged dual antiplatelet therapy
- •Female of child birth potential unless on effective contraception
- •Other medical condition that may limit survival
Outcomes
Primary Outcomes
Neointima hyperplasia volume by Intravascular Ultrasound
Time Frame: 9 months
Secondary Outcomes
- All cause mortality(5 years)
- Cardiovascular mortality(5 years)
- Target lesion revascularization(5 years)
- Angiographic late loss(9 months)
- Stent thrombosis(5 years)
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Not Applicable
Efficacy and Safety of Polymer-free Amphilimus-eluting Stent According to the DiabetesDiabetes MellitusCoronary Artery DiseaseNCT05759676Korea University Anam Hospital1,800
Unknown
Not Applicable
Xience Versus Synergy in Left Main PCICoronary Artery DiseaseNCT02303717NHS National Waiting Times Centre Board818
Terminated
Not Applicable
Nobori And Uncoated Stent In Coronary AttackAcute Myocardial InfarctionNCT01401036Shigeru Saito1,537
Completed
Not Applicable
Drug Eluting Stent Zilver PTX vs Bare Metal Stent Zilver FlexVascular DiseasesNCT05296031Skane University Hospital49
Completed
Not Applicable
Bare -Metal Stents and Drug -Eluting Stents in the Treatment of Patients With Vertebral Artery Ostium StenosisIschemic StrokeNCT02197559Xuanwu Hospital, Beijing168