Assessment of Stent Strut Coverage and Endothelial Function After Drug-Eluting Stents

Not Applicable

Withdrawn

• Conditions: Coronary Artery Disease; Atherosclerosis
• Interventions: Device: sirolimus-eluting stents (CYPHER SELECT® PLUS); Device: zotarolimus-eluting stent (ENDEAVOR®); Device: everolimus-eluting stents (PROMUS®)

• 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

Study Timeline

• Study First Submitted: 2010-02-22
• Study First Submitted QC: 2010-02-22
• Study First Posted: 2010-02-23
• Study Start: 2010-04
• Primary Completion: 2011-10
• Status Verified: 2017-02
• Study Completion: 2017-02
• Last Update Submitted: 2018-08-01
• Last Update Posted: 2018-08-03

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• Status: WITHDRAWN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

Arm && Interventions

Group	Intervention	Description
sirolimus-eluting stents (CYPHER SELECT® PLUS)	sirolimus-eluting stents (CYPHER SELECT® PLUS)	-
zotarolimus-eluting stents (ENDEAVOR®)	zotarolimus-eluting stent (ENDEAVOR®)	-
everolimus-eluting stents (PROMUS®)	everolimus-eluting stents (PROMUS®)	-

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

Trial Locations

Locations (1)

Hyogo College of Medicine; 🇯🇵 Nishinomiya, Japan