Comparison of the Biolimus A9-eluting Stent With the Zotarolimus -Eluting Stent in Multi-vessel PCI
- Conditions
- Multivessel Coronary Artery Disease
- Interventions
- Procedure: Percutaneous Coronary Intervention
- Registration Number
- NCT01947439
- Lead Sponsor
- Keimyung University Dongsan Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 932
- patients who need multi-vessel stenting with multi-vessel disease
- patients with signed informed consent
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Biolimus A9 eluting stent Percutaneous Coronary Intervention biolimus A9 stent( Biomatrix or Biomatrix Flex) will be placed in under Percutaneous Coronary Intervention. Zotarolimus-eluting stent Percutaneous Coronary Intervention zotarolimus eluting stent (Resolute Integrity) will be placed in under Percutaneous Coronary Intervention.
- Primary Outcome Measures
Name Time Method 2-year composite end points up to 2 years All cause death, non fatal myocardial infarction, any revascularization
- Secondary Outcome Measures
Name Time Method stent thrombosis up to 2 years stent thrombosis
Any revascularization up to 2 years Any revascularization
non fatal myocardial infarction up to 2 years non fatal myocardial infarction
cardiac death up to 2 years cardiac death
Target lesion revascularization up to 2 years Target lesion revascularization
Target vessel revascularization up to 2 years Target vessel revascularization
All cause death up to 2 years All cause death
non-cardiac death up to 2 years non-cardiac death
Trial Locations
- Locations (9)
Chonnam National University Hospital
🇰🇷Kwangju, Chonnam, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Gyeongbuk, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Kosin University Hospital
🇰🇷Busan, Korea, Republic of
Inje University Ilsan Paik Hospital
🇰🇷Ilsan, Kyeongki, Korea, Republic of
KyungPook National University Hospital
🇰🇷Daegu, Korea, Republic of
Yeungnam University Hospital
🇰🇷Daegu, Korea, Republic of
Daegu Fatima Hospital
🇰🇷Daegu, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of