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

Keimyung University

Status: Completed

Conditions: Multivessel Coronary Artery Disease

Treatments: Procedure: Percutaneous Coronary Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01947439

BATTLE IN MULTI

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 932 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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932 participants in 2 patient groups

Biolimus A9 eluting stent

Experimental group

Description:

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

Treatment:

Procedure: Percutaneous Coronary Intervention

Zotarolimus-eluting stent

Active Comparator group

Description:

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

Treatment:

Procedure: Percutaneous Coronary Intervention