NCT04825886

Brief Summary

This study is to evaluation the efficacy and safety of Zotarolimus-Eluting Stent in patients with long coronary artery disease of 25 mm or longer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
1 country

20 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

December 28, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2021

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2022

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

3.2 years

First QC Date

March 27, 2021

Last Update Submit

February 5, 2024

Conditions

Coronary Artery DiseaseMyocardial IschemiaCoronary Disease

Keywords

Coronary Artery DiseaseZotarolimus-Eluting StentLong Coronary Artery DiseaseTarget lesion failure

Outcome Measures

Primary Outcomes (1)

  • Target lesion failure

    Composite endpoint of clinically driven target lesion revascularization, myocardial infarction or cardiac death related to target vessel

    Index admission to 12 months

Secondary Outcomes (8)

  • All-cause death

    Index admission, 1 month, 6 months, 12 months

  • Cardiac death

    Index admission, 1 month, 6 months, 12 months

  • Myocardial Infarction

    Index admission, 1 month, 6 months, 12 months

  • All-cause death or Myocardial infarction

    Index admission, 1 month, 6 months, 12 months

  • Cardiac death or Myocardial infarction

    Index admission, 1 month, 6 months, 12 months

  • +3 more secondary outcomes

Interventions

Zotarolimus-Eluting StentDEVICE

Percutaneous coronary intervention using zotarolimus-eluting stent

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Coronary artery disease

You may qualify if:

  • Age ≥ 19 years old
  • Evidence of myocardial ischemia and coronary artery diameter stenosis≥ 50% and lesion length ≥ 25mm
  • At least 2.5 mm diameter coronary vessel by visual estimation
  • Patients treated with Zotarolimus-eluting stent

You may not qualify if:

  • Previous coronary stent implantation
  • Patients perticipated in other clinical trials of drugs or device
  • Target vessel saphenous vein graft
  • In-stent re-stenosis lesion
  • Contraindicated to anti-platelet agents or hypersensitivity
  • Past history of malignancy within 5 years
  • History of anaphylaxis to contrast agent
  • Pregnancy and lactation
  • Life expectancy \< 1-year
  • End stage renal disease on dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Gyeongsang National University Changwon Hospital

Changwon, South Korea

Location

Dankook University Hospital

Cheonan, South Korea

Location

Konkuk University Medical Center

Chungju, South Korea

Location

Daegu Catholic University Hospital

Daegu, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Kyungpook National University Hospital

Daegu, South Korea

Location

Yeungnam University Medical Center

Daegu, South Korea

Location

Eulji Medical Center

Daejeon, South Korea

Location

Kongyang Univeristy Hospital

Daejeon, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Chosun University Hospital

Gwangju, South Korea

Location

Wongkwang University Hospital

Iksan, South Korea

Location

Jeonbuk National University Hospital

Jeonju, South Korea

Location

Presbyterian Medical Center

Jeonju, South Korea

Location

Dong-A University Hospital

Pusan, South Korea

Location

Kosin University Gospel Hospital

Pusan, South Korea

Location

Paik Hospital

Pusan, South Korea

Location

Pusan National University Hospital

Pusan, South Korea

Location

Saint Carollo Hospital

Suncheon, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, South Korea

Location

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial IschemiaCoronary Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Youngkeun Ahn, MD

    Chonnam National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 27, 2021

First Posted

April 1, 2021

Study Start

December 28, 2017

Primary Completion

March 18, 2021

Study Completion

March 18, 2022

Last Updated

February 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(20)