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Clinical Trials/NCT01268371
NCT01268371UnknownPhase 4

Comparison of Biolimus-eluting Biodegradable Polymer, Everolimus-eluting and Sirolimus-eluting Coronary Stents

Ajou University School of Medicine26 sites in 1 country1,462 target enrollmentStarted: December 1, 2010Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Sponsor
Enrollment
1,462
Locations
26
Primary Endpoint
The Number of Participants with Majour Adverse Cardiac Events (composite of death, myocardial infarction, target vessel revascularization and stent thrombosis
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To compare the safety and efficacy of coronary stenting with everolimus-eluting stent (Promus Element®) and biolimus-eluting stent with biodegradable polymer (Nobori®)

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Significant coronary artery stenosis (> 50% by visual estimate)
  • •Stable angina, unstable angina, Non-ST elevation myocardial infarction (NSTEMI) and documented silent ischemia
  • •Patients eligible for intracoronary stenting
  • •age ≥ 20 years old

Exclusion Criteria

  • •ST segment elevation myocardial infarction (within 24 hours)
  • •Low ejection fraction (< 25%)
  • •Cardiogenic shock
  • •History of bleeding diathesis or known coagulopathy
  • •Limited life-expectancy (less than 1 year) due to combined serious disease
  • •Contraindication to heparin, sirolimus, everolimus and biolimus
  • •Contraindication to aspirin and clopidogrel
  • •Pregnancy

Outcomes

Primary Outcomes

The Number of Participants with Majour Adverse Cardiac Events (composite of death, myocardial infarction, target vessel revascularization and stent thrombosis

Time Frame: 1 year after index procedure

Secondary Outcomes

  • In-stent and in-segment late loss at 1 year angiographic follow-up(1 year after index procedure)
  • The number of participants with majour adverse cardiac events (composite of death, myocardial infarction, target vessel revascularization and stent thrombosis(2 years after index procedure)
  • Death (all-cause and cardiac)(1 to 2 years after index procedure)
  • Myocardial infarction (Q wave and non-Q wave)(1 to 2 years after index procedure)
  • Target vessel revascularization (ischemia- and clinically-driven)(1 to 2 years after index procedure)
  • Target lesion revascularization (ischemia- and clinically-driven)(1 to 2 years after index procedure)
  • Stent thrombosis(1 to 2 years after index procedure)
  • In-stent and in-segment restenosis at 1 year angiographic follow-up(1 year after index procedure)
  • Incidence and angiographic pattern of restenosis at 1 year angiographic follow-up(1 year after index procedure)
  • The incidence of Procedural success(index procedure (day 0))
  • The number of participants with death and myocardial infarction(1 to 2 years after index procedure)

Investigators

Sponsor
Ajou University School of Medicine
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Seung-Jea Tahk

Dr.

Ajou University School of Medicine

Study Sites (26)

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