search
Back to results

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

Primary Purpose

Multivessel Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Percutaneous Coronary Intervention
Sponsored by
Keimyung University Dongsan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multivessel Coronary Artery Disease focused on measuring multivessel stenting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Chonnam National University Hospital
  • Ulsan University Hospital
  • Inje University Ilsan Paik Hospital
  • Kosin University Hospital
  • Daegu Catholic University Medical Center
  • Daegu Fatima Hospital
  • KyungPook National University Hospital
  • Yeungnam University Hospital
  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Biolimus A9 eluting stent

Zotarolimus-eluting stent

Arm Description

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

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

Outcomes

Primary Outcome Measures

2-year composite end points
All cause death, non fatal myocardial infarction, any revascularization

Secondary Outcome Measures

All cause death
All cause death
non-cardiac death
non-cardiac death
cardiac death
cardiac death
non fatal myocardial infarction
non fatal myocardial infarction
Any revascularization
Any revascularization
Target lesion revascularization
Target lesion revascularization
Target vessel revascularization
Target vessel revascularization
stent thrombosis
stent thrombosis

Full Information

First Posted
September 12, 2013
Last Updated
August 31, 2021
Sponsor
Keimyung University Dongsan Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01947439
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2021 (Actual)
Study Completion Date
June 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Keimyung University Dongsan Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multivessel Coronary Artery Disease
Keywords
multivessel stenting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
932 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biolimus A9 eluting stent
Arm Type
Experimental
Arm Description
biolimus A9 stent( Biomatrix or Biomatrix Flex) will be placed in under Percutaneous Coronary Intervention.
Arm Title
Zotarolimus-eluting stent
Arm Type
Active Comparator
Arm Description
zotarolimus eluting stent (Resolute Integrity) will be placed in under Percutaneous Coronary Intervention.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Coronary Intervention
Other Intervention Name(s)
-Resolute Integrity, -Biomatrix, -Biomatrix Flex
Intervention Description
Percutaneous Transluminal coronary angioplasty and Intervention will be performed in both of randomized groups of biolimus A9 eluting stent and zotarolimus eluting stent
Primary Outcome Measure Information:
Title
2-year composite end points
Description
All cause death, non fatal myocardial infarction, any revascularization
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
All cause death
Description
All cause death
Time Frame
up to 2 years
Title
non-cardiac death
Description
non-cardiac death
Time Frame
up to 2 years
Title
cardiac death
Description
cardiac death
Time Frame
up to 2 years
Title
non fatal myocardial infarction
Description
non fatal myocardial infarction
Time Frame
up to 2 years
Title
Any revascularization
Description
Any revascularization
Time Frame
up to 2 years
Title
Target lesion revascularization
Description
Target lesion revascularization
Time Frame
up to 2 years
Title
Target vessel revascularization
Description
Target vessel revascularization
Time Frame
up to 2 years
Title
stent thrombosis
Description
stent thrombosis
Time Frame
up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang-Wook Nam, Postdoctoral
Organizational Affiliation
Keimyung University Dongsan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonnam National University Hospital
City
Kwangju
State/Province
Chonnam
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
State/Province
Gyeongbuk
Country
Korea, Republic of
Facility Name
Inje University Ilsan Paik Hospital
City
Ilsan
State/Province
Kyeongki
Country
Korea, Republic of
Facility Name
Kosin University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Daegu Catholic University Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Daegu Fatima Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
KyungPook National University Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Yeungnam University Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs