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

Primary Purpose

Coronary Artery Disease, Atherosclerosis

Status
Withdrawn
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
zotarolimus-eluting stent (ENDEAVOR®)
sirolimus-eluting stents (CYPHER SELECT® PLUS)
everolimus-eluting stents (PROMUS®)
Sponsored by
Hyogo Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hyogo College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

zotarolimus-eluting stents (ENDEAVOR®)

sirolimus-eluting stents (CYPHER SELECT® PLUS)

everolimus-eluting stents (PROMUS®)

Arm Description

Outcomes

Primary Outcome Measures

To compare coronary endothelial function after primary angioplasty.
To compare the presence of neointimal stent strut coverage via optical coherence tomography.
To compare the serum biomarker levels measured in coronary artery blood.

Secondary Outcome Measures

Full Information

First Posted
February 22, 2010
Last Updated
August 1, 2018
Sponsor
Hyogo Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01073111
Brief Title
Assessment of Stent Strut Coverage and Endothelial Function After Drug-Eluting Stents
Acronym
ASSESS
Official Title
Assessment of Neointimal Stent Strut Coverage and Endothelial Function After Second Generation Drug-Eluting Stent Systems
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Withdrawn
Study Start Date
April 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hyogo Medical University

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Atherosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
zotarolimus-eluting stents (ENDEAVOR®)
Arm Type
Active Comparator
Arm Title
sirolimus-eluting stents (CYPHER SELECT® PLUS)
Arm Type
Active Comparator
Arm Title
everolimus-eluting stents (PROMUS®)
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
zotarolimus-eluting stent (ENDEAVOR®)
Intervention Description
zotarolimus-eluting stent
Intervention Type
Device
Intervention Name(s)
sirolimus-eluting stents (CYPHER SELECT® PLUS)
Intervention Description
sirolimus-eluting stents
Intervention Type
Device
Intervention Name(s)
everolimus-eluting stents (PROMUS®)
Intervention Description
everolimus-eluting stents
Primary Outcome Measure Information:
Title
To compare coronary endothelial function after primary angioplasty.
Time Frame
6 months and 12 months
Title
To compare the presence of neointimal stent strut coverage via optical coherence tomography.
Time Frame
6 months and 12 months
Title
To compare the serum biomarker levels measured in coronary artery blood.
Time Frame
6 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hyogo College of Medicine
City
Nishinomiya
ZIP/Postal Code
6638501
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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