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

Assessment of Neointimal Stent Strut Coverage and Endothelial Function After Second Generation Drug-Eluting Stent Systems

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01073111

Acronym

ASSESS

Enrollment

Registered

2010-02-23

Start date

2010-04-30

Completion date

2017-02-28

Last updated

2018-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Coronary Artery Disease

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.

Interventions

DEVICEzotarolimus-eluting stent (ENDEAVOR®)

zotarolimus-eluting stent

DEVICEsirolimus-eluting stents (CYPHER SELECT® PLUS)

sirolimus-eluting stents

DEVICEeverolimus-eluting stents (PROMUS®)

everolimus-eluting stents

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

25 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026