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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

932 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2021-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Multivessel Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Biolimus A9 eluting stent

biolimus A9 stent( Biomatrix or Biomatrix Flex) will be placed in under Percutaneous Coronary Intervention.

Group Type EXPERIMENTAL

Percutaneous Coronary Intervention

Intervention Type PROCEDURE

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

Zotarolimus-eluting stent

zotarolimus eluting stent (Resolute Integrity) will be placed in under Percutaneous Coronary Intervention.

Group Type ACTIVE_COMPARATOR

Percutaneous Coronary Intervention

Intervention Type PROCEDURE

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

Interventions

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Percutaneous Coronary Intervention

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

Intervention Type PROCEDURE

Other Intervention Names

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-Resolute Integrity -Biomatrix -Biomatrix Flex

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No