Assessment of Stent Strut Coverage and Endothelial Function After Drug-Eluting Stents
Not Applicable
Withdrawn
- Conditions
- Coronary Artery DiseaseAtherosclerosis
- Registration Number
- NCT01073111
- Lead Sponsor
- Hyogo Medical University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To compare coronary endothelial function after primary angioplasty. 6 months and 12 months To compare the presence of neointimal stent strut coverage via optical coherence tomography. 6 months and 12 months To compare the serum biomarker levels measured in coronary artery blood. 6 months and 12 months
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
How do mTOR inhibitors in zotarolimus, sirolimus, and everolimus stents affect neointimal coverage in coronary artery disease?
What comparative effectiveness data exist for second-generation drug-eluting stents in reducing restenosis vs. standard-of-care devices?
Which coronary biomarkers correlate with endothelial function improvement after ENDEAVOR® vs. PROMUS® stent implantation?
What adverse events are associated with late stent thrombosis in zotarolimus-eluting stents compared to sirolimus/everolimus variants?
How do Hyogo Medical University's findings on stent strut coverage relate to competitor drug-eluting stents in atherosclerosis management?
Trial Locations
- Locations (1)
Hyogo College of Medicine
🇯🇵Nishinomiya, Japan
Hyogo College of Medicine🇯🇵Nishinomiya, Japan