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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Hyogo College of Medicine
Sponsor:
Information provided by (Responsible Party):
Kenichi Fujii, Hyogo College of Medicine
ClinicalTrials.gov Identifier:
NCT01073111
First received: February 22, 2010
Last updated: March 18, 2013
Last verified: March 2013

February 22, 2010
March 18, 2013
April 2010
October 2011   (final data collection date for primary outcome measure)
  • To compare coronary endothelial function after primary angioplasty. [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • To compare the presence of neointimal stent strut coverage via optical coherence tomography. [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • To compare the serum biomarker levels measured in coronary artery blood. [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01073111 on ClinicalTrials.gov Archive Site
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Assessment of Stent Strut Coverage and Endothelial Function After Drug-Eluting Stents
Assessment of Neointimal Stent Strut Coverage and Endothelial Function After Second Generation Drug-Eluting Stent Systems

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Coronary Artery Disease
  • Atherosclerosis
  • Device: zotarolimus-eluting stent (ENDEAVOR®)
    zotarolimus-eluting stent
  • Device: sirolimus-eluting stents (CYPHER SELECT® PLUS)
    sirolimus-eluting stents
  • Device: everolimus-eluting stents (PROMUS®)
    everolimus-eluting stents
  • Active Comparator: zotarolimus-eluting stents (ENDEAVOR®)
    Intervention: Device: zotarolimus-eluting stent (ENDEAVOR®)
  • Active Comparator: sirolimus-eluting stents (CYPHER SELECT® PLUS)
    Intervention: Device: sirolimus-eluting stents (CYPHER SELECT® PLUS)
  • Active Comparator: everolimus-eluting stents (PROMUS®)
    Intervention: Device: everolimus-eluting stents (PROMUS®)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
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October 2011   (final data collection date for primary outcome measure)

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
Both
25 Years to 80 Years
No
Contact: Kenichi Fujii +81798456553 kfujii@hyo-med.ac.jp
Japan
 
NCT01073111
ASSESS
Not Provided
Kenichi Fujii, Hyogo College of Medicine
Hyogo College of Medicine
Not Provided
Not Provided
Hyogo College of Medicine
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP