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

August 1, 2018 updated by: Kenichi Fujii, Hyogo College of Medicine

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Nishinomiya, Japan, 6638501
        • Hyogo College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare coronary endothelial function after primary angioplasty.
Time Frame: 6 months and 12 months
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
6 months and 12 months
To compare the serum biomarker levels measured in coronary artery blood.
Time Frame: 6 months and 12 months
6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hyogo College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

February 22, 2010

First Submitted That Met QC Criteria

February 22, 2010

First Posted (Estimate)

February 23, 2010

Study Record Updates

Last Update Posted (Actual)

August 3, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASSESS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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