Assessment of Neointimal Stent Strut Coverage and Endothelial Function After Second Generation Drug-Eluting Stent Systems
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Hyogo Medical University
- Locations
- 1
- Primary Endpoint
- To compare coronary endothelial function after primary angioplasty.
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to compare coronary endothelium function in patients with a zotarolimus-eluting versus a sirolimus-eluting or a everolimus-eluting stents with optical coherence tomography, vasoconstriction in response to acetylcholine, and coronary biomarker level.
Investigators
Kenichi Fujii
Assistant Professor
Hyogo Medical University
Eligibility Criteria
Inclusion Criteria
- •Significant coronary de novo lesion (\> 70% by quantitative angiographic analysis)
- •Patients with stable or acute coronary syndrome considered for coronary revascularization
- •Reference vessel diameter of 2.5 to 3.5 mm by operator assessment
Exclusion Criteria
- •Contraindication to anti-platelet agents
- •Ostial lesion within 5 mm from ostium
- •Different DES in other vessel simultaneously
- •Creatinine level 2.5 mg/dL
- •Left main stenosis more than 50%.
- •vein graft lesion
- •Triple vessel disease with stenosis more than 50% in 3 epicardial coronary arteries
- •Life expectancy 1 year
- •Reference vessel \< 2.5 mm or \> 4.0 mm diameter by visual
- •Long lesion that require more than three stents
Outcomes
Primary Outcomes
To compare coronary endothelial function after primary angioplasty.
Time Frame: 6 months and 12 months
To compare the presence of neointimal stent strut coverage via optical coherence tomography.
Time Frame: 6 months and 12 months
To compare the serum biomarker levels measured in coronary artery blood.
Time Frame: 6 months and 12 months