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NCT01073111 Clinical Trial

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

Coronary Artery Disease Clinical Trial

— ASSESS  

Official title:
Assessment of Neointimal Stent Strut Coverage and Endothelial Function After Second Generation Drug-Eluting Stent Systems

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01073111
Other study ID # ASSESS
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date April 2010
Est. completion date February 2017

Study information
Verified date February 2017
Source Hyogo College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date February 2017
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender All
Age group 25 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• zotarolimus-eluting stent (ENDEAVOR®)
zotarolimus-eluting stent
• sirolimus-eluting stents (CYPHER SELECT® PLUS)
sirolimus-eluting stents
• everolimus-eluting stents (PROMUS®)
everolimus-eluting stents

Locations
Country Name City State
Japan Hyogo College of Medicine Nishinomiya

Sponsors (1)
Lead Sponsor Collaborator
Hyogo College of Medicine

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary To compare coronary endothelial function after primary angioplasty. 6 months and 12 months
Primary To compare the presence of neointimal stent strut coverage via optical coherence tomography. 6 months and 12 months
Primary To compare the serum biomarker levels measured in coronary artery blood. 6 months and 12 months
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