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Clinical Trials/NCT01073111
NCT01073111
Withdrawn
Not Applicable

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

Hyogo Medical University1 site in 1 countryApril 2010

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Withdrawn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.

Registry
clinicaltrials.gov
Start Date
April 2010
End Date
February 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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

Study Sites (1)

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