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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Seung-Jea Tahk, Ajou University School of Medicine
ClinicalTrials.gov Identifier:
NCT01268371
First received: December 29, 2010
Last updated: February 11, 2014
Last verified: February 2014

December 29, 2010
February 11, 2014
December 2010
July 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
The composite of death, myocardial infarction, target vessel revascularization and stent thrombosis [ Time Frame: 1 year after index procedure ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01268371 on ClinicalTrials.gov Archive Site
  • The number of participants with majour adverse cardiac events (composite of death, myocardial infarction, target vessel revascularization and stent thrombosis [ Time Frame: 2 years after index procedure ] [ Designated as safety issue: Yes ]
  • Death (all-cause and cardiac) [ Time Frame: 1 to 2 years after index procedure ] [ Designated as safety issue: Yes ]
  • Myocardial infarction (Q wave and non-Q wave) [ Time Frame: 1 to 2 years after index procedure ] [ Designated as safety issue: Yes ]
  • Target vessel revascularization (ischemia- and clinically-driven) [ Time Frame: 1 to 2 years after index procedure ] [ Designated as safety issue: No ]
  • Target lesion revascularization (ischemia- and clinically-driven) [ Time Frame: 1 to 2 years after index procedure ] [ Designated as safety issue: No ]
  • Stent thrombosis [ Time Frame: 1 to 2 years after index procedure ] [ Designated as safety issue: Yes ]
  • In-stent and in-segment late loss at 1 year angiographic follow-up [ Time Frame: 1 year after index procedure ] [ Designated as safety issue: No ]
  • In-stent and in-segment restenosis at 1 year angiographic follow-up [ Time Frame: 1 year after index procedure ] [ Designated as safety issue: No ]
  • Incidence and angiographic pattern of restenosis at 1 year angiographic follow-up [ Time Frame: 1 year after index procedure ] [ Designated as safety issue: No ]
  • The incidence of Procedural success [ Time Frame: index procedure (day 0) ] [ Designated as safety issue: No ]
  • The number of participants with death and myocardial infarction [ Time Frame: 1 to 2 years after index procedure ] [ Designated as safety issue: Yes ]
  • The composite of death, myocardial infarction, target vessel revascularization and stent thrombosis [ Time Frame: 2 years after index procedure ] [ Designated as safety issue: Yes ]
  • Death (all-cause and cardiac) [ Time Frame: 1 to 2 years after index procedure ] [ Designated as safety issue: Yes ]
  • Myocardial infarction (Q wave and non-Q wave) [ Time Frame: 1 to 2 years after index procedure ] [ Designated as safety issue: Yes ]
  • Target vessel revascularization (ischemia- and clinically-driven) [ Time Frame: 1 to 2 years after index procedure ] [ Designated as safety issue: No ]
  • Target lesion revascularization (ischemia- and clinically-driven) [ Time Frame: 1 to 2 years after index procedure ] [ Designated as safety issue: No ]
  • Stent thrombosis [ Time Frame: 1 to 2 years after index procedure ] [ Designated as safety issue: Yes ]
  • In-stent and in-segment late loss at 1 year angiographic follow-up [ Time Frame: 1 year after index procedure ] [ Designated as safety issue: No ]
  • In-stent and in-segment restenosis at 1 year angiographic follow-up [ Time Frame: 1 year after index procedure ] [ Designated as safety issue: No ]
  • Incidence and angiographic pattern of restenosis at 1 year angiographic follow-up [ Time Frame: 1 year after index procedure ] [ Designated as safety issue: No ]
  • Procedural success [ Time Frame: index procedure (day 0) ] [ Designated as safety issue: No ]
  • The composite of death and myocardial infarction [ Time Frame: 1 to 2 years after index procedure ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Comparison of Biolimus-eluting Biodegradable Polymer, Everolimus-eluting and Sirolimus-eluting Coronary Stents
Comparison of Biolimus-eluting Biodegradable Polymer, Everolimus-eluting and Sirolimus-eluting Coronary Stents

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Coronary Artery Disease
  • Device: Promus Element, Boston Scientific Corporation
    Everolimus-eluting stent
    Other Name: Everolimus-eluting stent
  • Device: Nobori, Terumo Corporation (Japan)
    Biolimus-eluting stent with biodegradable polymer
    Other Name: Biolimus-eluting stent with biodegradable polymer
  • Active Comparator: Promus Element
    Everolimus-eluting stent
    Intervention: Device: Promus Element, Boston Scientific Corporation
  • Active Comparator: Nobori
    Biolimus-eluting stent with biodegradable polymer
    Intervention: Device: Nobori, Terumo Corporation (Japan)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1462
July 2015
July 2015   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01268371
BESS
Yes
Seung-Jea Tahk, Ajou University School of Medicine
Ajou University School of Medicine
Not Provided
Principal Investigator: Seung-Jea Tahk, MD, PhD Department of Cardiology, Ajou University School of Medicine
Ajou University School of Medicine
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP