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NCT Number: NCT01947439

Comparison of the Biolimus A9-eluting Stent With the Zotarolimus -Eluting Stent in Multi-vessel PCI

The risk of restenosis in the treatment of coronary artery disease has significantly lessened thanks to the introduction of Drug eluting stent.

Yet, debates on the efficacy and safety of stents in complex lesions or patients have been circulated.

Recently, PCI in multiple lesions is universally performed with the development of effective stents in various kinds in the clinics.

However, a randomized study is rare for multi-vessel coronary artery disease in real procedural environments.

The primary purpose of this study is to evaluate the clinical progress of biolimus A9-eluting stent and zotarolimus-eluting stent in multi-vessel coronary artery disease.

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Key information

Conditions

Multivessel Coronary Artery Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chonnam National University Hospital, Kwangju, Chonnam, South Korea

Loading trial locations.

About this study

The patients who need multi-vessel stenting with multi-vessel coronary artery disease will be enrolled.Each randomization of the enrolled subjects will be done 1:1 (biolimus A9-eluting stent : zotarolimus-eluting stent). Randomization will be stratified by two factors: Diabetes mellitus and Acute coronary syndrome.Clinical follow-up will occur at the following time points; 1 month, 1 year and 2 years.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients who need multi-vessel stenting with multi-vessel disease
  • patients with signed informed consent

Exclusion criteria

  • known contraindication to any of the following medications: Aspirin,clopidogrel, heparin, contrast agent, Biolimus or Zotarolimus group
  • Cardiogenic shock
  • Pregnant women or women with potential childbearing
  • End-stage diseases with life expectancy shorter than 2 years
  • patients with other Drug eluting stents implanted
  • Patients requiring modification of antiplatelet agents for planned major surgery within the first 12 months after the enrollment.

Treatment and study plan

Percutaneous coronary intervention

Procedure

Percutaneous Transluminal coronary angioplasty and Intervention will be performed in both of randomized groups of biolimus A9 eluting stent and zotarolimus eluting stent

Other names: -Resolute Integrity, -Biomatrix, -Biomatrix Flex

Primary outcomes

  1. 2-year composite end points

    Time frame: up to 2 years

    All cause death, non fatal myocardial infarction, any revascularization

Secondary outcomes

  1. All cause death

    Time frame: up to 2 years

    All cause death

  2. non-cardiac death

    Time frame: up to 2 years

    non-cardiac death

  3. cardiac death

    Time frame: up to 2 years

    cardiac death

  4. non fatal myocardial infarction

    Time frame: up to 2 years

    non fatal myocardial infarction

  5. Any revascularization

    Time frame: up to 2 years

    Any revascularization

  6. Target lesion revascularization

    Time frame: up to 2 years

    Target lesion revascularization

  7. Target vessel revascularization

    Time frame: up to 2 years

    Target vessel revascularization

  8. stent thrombosis

    Time frame: up to 2 years

    stent thrombosis

Sponsors and collaborators

Lead sponsor

Keimyung University Dongsan Medical Center

Other

Registry information

Official study title

Prospective,Multicenter Study of Randomized Comparison of the Biolimus A9-eluting Stent With the Zotarolimus-eluting Stent in Multi-vessel PCI

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Sep 20, 2013
Registry last updated
Sep 1, 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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