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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01073111
Recruitment Status : Unknown
Verified March 2013 by Kenichi Fujii, Hyogo College of Medicine.
Recruitment status was:  Recruiting
First Posted : February 23, 2010
Last Update Posted : March 20, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Neointimal Stent Strut Coverage and Endothelial Function After Second Generation Drug-Eluting Stent Systems
Study Start Date : April 2010
Primary Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. To compare coronary endothelial function after primary angioplasty. [ Time Frame: 6 months and 12 months ]
  2. To compare the presence of neointimal stent strut coverage via optical coherence tomography. [ Time Frame: 6 months and 12 months ]
  3. To compare the serum biomarker levels measured in coronary artery blood. [ Time Frame: 6 months and 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kenichi Fujii, Assistant Professor, Hyogo College of Medicine
ClinicalTrials.gov Identifier: NCT01073111     History of Changes
Other Study ID Numbers: ASSESS
First Posted: February 23, 2010    Key Record Dates
Last Update Posted: March 20, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Atherosclerosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents