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
  Purpose

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
Atherosclerosis
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

  Eligibility

Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01073111

Contacts
Contact: Kenichi Fujii +81798456553 kfujii@hyo-med.ac.jp

Locations
Japan
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
ClinicalTrials.gov 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:
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 26, 2014