Assessment of Stent Strut Coverage and Endothelial Function After Drug-Eluting Stents
ASSESS
Assessment of Neointimal Stent Strut Coverage and Endothelial Function After Second Generation Drug-Eluting Stent Systems
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2010
Longer than P75 for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2010
CompletedFirst Posted
Study publicly available on registry
February 23, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedAugust 3, 2018
February 1, 2017
1.5 years
February 22, 2010
August 1, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
To compare coronary endothelial function after primary angioplasty.
6 months and 12 months
To compare the presence of neointimal stent strut coverage via optical coherence tomography.
6 months and 12 months
To compare the serum biomarker levels measured in coronary artery blood.
6 months and 12 months
Study Arms (3)
zotarolimus-eluting stents (ENDEAVOR®)
ACTIVE COMPARATORsirolimus-eluting stents (CYPHER SELECT® PLUS)
ACTIVE COMPARATOReverolimus-eluting stents (PROMUS®)
ACTIVE COMPARATORInterventions
zotarolimus-eluting stent
sirolimus-eluting stents
everolimus-eluting stents
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hyogo College of Medicine
Nishinomiya, 6638501, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 22, 2010
First Posted
February 23, 2010
Study Start
April 1, 2010
Primary Completion
October 1, 2011
Study Completion
February 1, 2017
Last Updated
August 3, 2018
Record last verified: 2017-02