Clinical trial NCT01947439: Comparison of the Biolimus A9-eluting Stent With the Zotarolimus -Eluting Stent in Multi-vessel PCI
Official title: Prospective,Multicenter Study of Randomized Comparison of the Biolimus A9-eluting Stent With the Zotarolimus-eluting Stent in Multi-vessel PCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multivessel Coronary Artery Disease
Keywords: multivessel stenting
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2013-09-20
Enrollment: 932
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 2-year composite end points
timeFrame: up to 2 years
Secondary outcomes:
measure: All cause death
timeFrame: up to 2 years
measure: non-cardiac death
timeFrame: up to 2 years
measure: cardiac death
timeFrame: up to 2 years
measure: non fatal myocardial infarction
timeFrame: up to 2 years
measure: Any revascularization
timeFrame: up to 2 years
measure: Target lesion revascularization
timeFrame: up to 2 years
measure: Target vessel revascularization
timeFrame: up to 2 years
measure: stent thrombosis
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Kwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
state: Chonnam
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
state: Gyeongbuk
city: Ilsan
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
state: Kyeongki
city: Busan
country: Korea, Republic of
facility: Kosin University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Daegu Fatima Hospital
city: Daegu
country: Korea, Republic of
facility: KyungPook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Keimyung University Dongsan Medical Center
name: Chang-Wook Nam, Postdoctoral
role: PRINCIPAL_INVESTIGATOR
References: