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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01947439
Other study ID # BATTLE IN MULTI
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2013
Est. completion date June 2021

Study information

Verified date August 2021
Source Keimyung University Dongsan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 932
Est. completion date June 2021
Est. primary completion date June 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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

Locations

Country Name City State
Korea, Republic of Kosin University Hospital Busan
Korea, Republic of Daegu Catholic University Medical Center Daegu
Korea, Republic of Daegu Fatima Hospital Daegu
Korea, Republic of KyungPook National University Hospital Daegu
Korea, Republic of Yeungnam University Hospital Daegu
Korea, Republic of Inje University Ilsan Paik Hospital Ilsan Kyeongki
Korea, Republic of Chonnam National University Hospital Kwangju Chonnam
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Ulsan University Hospital Ulsan Gyeongbuk

Sponsors (1)

Lead Sponsor Collaborator
Keimyung University Dongsan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 2-year composite end points All cause death, non fatal myocardial infarction, any revascularization up to 2 years
Secondary All cause death All cause death up to 2 years
Secondary non-cardiac death non-cardiac death up to 2 years
Secondary cardiac death cardiac death up to 2 years
Secondary non fatal myocardial infarction non fatal myocardial infarction up to 2 years
Secondary Any revascularization Any revascularization up to 2 years
Secondary Target lesion revascularization Target lesion revascularization up to 2 years
Secondary Target vessel revascularization Target vessel revascularization up to 2 years
Secondary stent thrombosis stent thrombosis up to 2 years
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