NCT01947439

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
932

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2013

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

8.3 years

First QC Date

September 12, 2013

Last Update Submit

August 31, 2021

Conditions

Multivessel Coronary Artery Disease

Keywords

multivessel stenting

Outcome Measures

Primary Outcomes (1)

  • 2-year composite end points

    All cause death, non fatal myocardial infarction, any revascularization

    up to 2 years

Secondary Outcomes (8)

  • All cause death

    up to 2 years

  • non-cardiac death

    up to 2 years

  • cardiac death

    up to 2 years

  • non fatal myocardial infarction

    up to 2 years

  • Any revascularization

    up to 2 years

  • +3 more secondary outcomes

Study Arms (2)

Biolimus A9 eluting stent

EXPERIMENTAL

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

Procedure: Percutaneous Coronary Intervention

Zotarolimus-eluting stent

ACTIVE COMPARATOR

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

Procedure: Percutaneous Coronary Intervention

Interventions

Percutaneous Coronary InterventionPROCEDURE

Percutaneous Transluminal coronary angioplasty and Intervention will be performed in both of randomized groups of biolimus A9 eluting stent and zotarolimus eluting stent

Also known as: -Resolute Integrity, -Biomatrix, -Biomatrix Flex
Biolimus A9 eluting stentZotarolimus-eluting stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who need multi-vessel stenting with multi-vessel disease
  • patients with signed informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Chonnam National University Hospital

Kwangju, Chonnam, South Korea

Location

Ulsan University Hospital

Ulsan, Gyeongsangbuk-do, South Korea

Location

Inje University Ilsan Paik Hospital

Ilsan, Kyeongki, South Korea

Location

Kosin University Hospital

Busan, South Korea

Location

Daegu Catholic University Medical Center

Daegu, South Korea

Location

Daegu Fatima Hospital

Daegu, South Korea

Location

KyungPook National University Hospital

Daegu, South Korea

Location

Yeungnam University Hospital

Daegu, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

  • Lee CH, Lee HJ, Chung TW, Lee S, Hwang J, Kim IC, Cho YK, Yoon HJ, Hur SH, Kim JY, Kim YS, Jang WS, Lee JH, Kim W, Lee JB, Hong YJ, Heo JH, Lee BR, Doh JH, Shin ES, Koo BK, Nam CW. Comparison of Thick Biolimus A9-Eluting Stent and Thin Zotarolimus-Eluting Stent in Multi-Vessel Percutaneous Coronary Intervention. Korean Circ J. 2025 May;55(5):396-407. doi: 10.4070/kcj.2024.0101. Epub 2025 Feb 17.

    PMID: 40097279DERIVED

MeSH Terms

Interventions

Percutaneous Coronary InterventionBiomatrix preparation

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Chang-Wook Nam, Postdoctoral

    Keimyung University Dongsan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Internal Medicine

Study Record Dates

First Submitted

September 12, 2013

First Posted

September 20, 2013

Study Start

March 1, 2013

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

September 1, 2021

Record last verified: 2021-08

Locations

KR(9)