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

Multivessel Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01947439
• Other study ID #: BATTLE IN MULTI
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Multivessel Coronary Artery Disease

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