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

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

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.

Condition Intervention Phase
Coronary Artery Disease
Device: zotarolimus-eluting stent (ENDEAVOR®)
Device: sirolimus-eluting stents (CYPHER SELECT® PLUS)
Device: everolimus-eluting stents (PROMUS®)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Neointimal Stent Strut Coverage and Endothelial Function After Second Generation Drug-Eluting Stent Systems

Resource links provided by NLM:

Further study details as provided by Hyogo College of Medicine:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: April 2010
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: zotarolimus-eluting stents (ENDEAVOR®) Device: zotarolimus-eluting stent (ENDEAVOR®)
zotarolimus-eluting stent
Active Comparator: sirolimus-eluting stents (CYPHER SELECT® PLUS) Device: sirolimus-eluting stents (CYPHER SELECT® PLUS)
sirolimus-eluting stents
Active Comparator: everolimus-eluting stents (PROMUS®) Device: everolimus-eluting stents (PROMUS®)
everolimus-eluting stents


Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT01073111

Contact: Kenichi Fujii +81798456553

Hyogo College of Medicine Recruiting
Nishinomiya, Japan, 6638501
Sponsors and Collaborators
Hyogo College of Medicine
  More Information

No publications provided

Responsible Party: Kenichi Fujii, Assistant Professor, Hyogo College of Medicine Identifier: NCT01073111     History of Changes
Other Study ID Numbers: ASSESS
Study First Received: February 22, 2010
Last Updated: March 18, 2013
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents processed this record on April 15, 2014