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OpenTrials
Completed

NCT Number: NCT01711931

Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents

The purpose of this study is to compare the efficacy and safety of everolimus- and biolimus-bluting stents with everolimus-eluting bioresorbable vascular scaffold stents.

The null hypothesis to be rejected is that there is no significant difference with regard to lumen late loss at 9 months and a clinical end point of death, myocardial infarction and TVR at 12 months between everolimus-eluting and biolimus-eluting stents and everolimus-eluting bioresorbable vascular scaffold stents.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fribourg Cantonal Hospital

Fribourg, 1708, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • elective PCI
  • ability and willingness to provide written informed consent

Exclusion criteria

  • ST-elevation myocardial infarction in the previous 48 hours
  • moderate to severe renal failure (defined as creatinine clearance of 30-60 ml/min and <30ml/min respectively)
  • known or presumed hypersensitivity to heparin, antiplatelet drugs and hypersensitivity to contrast dye incontrollable with premedication

Treatment and study plan

Implantation of everolimus-eluting bioresorbable vascular scaffold stent

Device

Implantation of everolimus-eluting stents

Device

Implantation of biolimus-eluting stents

Device

Primary outcomes

  1. Lumen Late Loss

    Time frame: 9 months

    as assessed by quantitative coronary angiogram

Secondary outcomes

  1. Device-oriented major adverse cardiac events

    Time frame: 6 months, 1, 2, 5 years

    The composite of cardiac death, myocardial infarction (not clearly attributable to a nontarget vessel) and target lesion revascularization

  2. Patient-oriented major adverse cardiac events

    Time frame: 6 months, 1, 2, 5 years

    The composite of all-cause mortality, any myocardial infarction and any revascularization

Other outcomes

  1. Stent thrombosis

    Time frame: up to 5 years

    possible, probable and definite stent thrombosis

  2. Periprocedural Complications (occurring <48 hours after the Intervention)

    Time frame: Periprocedural

    Type 4A MI Dissection Perforation

Sponsors and collaborators

Lead sponsor

University of Freiburg

Other

Registry information

Acronym: EVERBIOII

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 22, 2012
Registry last updated
Oct 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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