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

H

Hyogo Medical University

Status

Withdrawn

Conditions

Coronary Artery Disease
Atherosclerosis

Treatments

Device: sirolimus-eluting stents (CYPHER SELECT® PLUS)
Device: everolimus-eluting stents (PROMUS®)
Device: zotarolimus-eluting stent (ENDEAVOR®)

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Sex

All

Ages

25 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 3 patient groups

zotarolimus-eluting stents (ENDEAVOR®)
Active Comparator group
Treatment:
Device: zotarolimus-eluting stent (ENDEAVOR®)
sirolimus-eluting stents (CYPHER SELECT® PLUS)
Active Comparator group
Treatment:
Device: sirolimus-eluting stents (CYPHER SELECT® PLUS)
everolimus-eluting stents (PROMUS®)
Active Comparator group
Treatment:
Device: everolimus-eluting stents (PROMUS®)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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