Efficacy and Safety of ZotaRolimus-Eluting Coronary Stent System In Patients With Long Coronary Artery Disease

February 5, 2024 updated by: Min Chul Kim, Chonnam National University Hospital

Evaluation of Effectiveness and Safety of ZotaRolimus-Eluting Coronary Stent System In Patients With Long Coronary Artery Disease; A Multicenter, Prospective, Observational Registry Study

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.

Study Overview

Detailed Description

Study objectives:

From this observational prospective study, the efficacy and safety of Zotarolimus-Eluting Stent in patients with coronary artery disease longer than 25mm is planned to be investigated.

Background:

Long coronary artery lesions are observed in 20% of all coronary interventions, and are associated with poor clinical outcomes. Zotarolimus-Eluting Stents are a new type of stent that combines the advantages of an Endeavour Resolute stent (drug eluting stent) and Integrity stent (bare metal stent). In other words, BioLinx polymer is used which is an advantage of Endeavour Resolute stent to secure clinical efficiency through stable drug release while ensuring flexibility and excellent deliverability, which is the advantage of Integrity stent. To date, there are only few studies to evaluate the efficacy and safety of Zotarolimus-Eluting Stent in the treatment of coronary artery disease. Therefore, the investigators planned to carry out a multicenter, prospective observational study to evaluated the efficacy and safety of Zotarolimus-Eluting Stent in patients with long coronary artery disease of 25 mm or longer.

Study Type

Observational

Enrollment (Actual)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Changwon, Korea, Republic of
        • Gyeongsang National University Changwon Hospital
      • Cheonan, Korea, Republic of
        • Dankook University Hospital
      • Chungju, Korea, Republic of
        • Konkuk University Medical Center
      • Daegu, Korea, Republic of
        • Keimyung University Dongsan Medical Center
      • Daegu, Korea, Republic of
        • Kyungpook National University Hospital
      • Daegu, Korea, Republic of
        • Yeungnam University Medical Center
      • Daegu, Korea, Republic of
        • Daegu Catholic University Hospital
      • Daejeon, Korea, Republic of
        • Eulji Medical Center
      • Daejeon, Korea, Republic of
        • Kongyang Univeristy Hospital
      • Gwangju, Korea, Republic of
        • Chonnam National University Hospital
      • Gwangju, Korea, Republic of
        • Chosun university hospital
      • Iksan, Korea, Republic of
        • Wongkwang University Hospital
      • Jeonju, Korea, Republic of
        • Presbyterian Medical Center
      • Jeonju, Korea, Republic of
        • Jeonbuk National University Hospital
      • Pusan, Korea, Republic of
        • Pusan National University Hospital
      • Pusan, Korea, Republic of
        • Dong-A University Hospital
      • Pusan, Korea, Republic of
        • Kosin University Gospel Hospital
      • Pusan, Korea, Republic of
        • Paik Hospital
      • Suncheon, Korea, Republic of
        • Saint Carollo Hospital
      • Yangsan, Korea, Republic of
        • Pusan National University Yangsan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Coronary artery disease

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target lesion failure
Time Frame: Index admission to 12 months
Composite endpoint of clinically driven target lesion revascularization, myocardial infarction or cardiac death related to target vessel
Index admission to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause death
Time Frame: Index admission, 1 month, 6 months, 12 months
Cumulative incidence rate of all-cause death at each visit
Index admission, 1 month, 6 months, 12 months
Cardiac death
Time Frame: Index admission, 1 month, 6 months, 12 months
Cumulative incidence rate of cardiac death at each visit
Index admission, 1 month, 6 months, 12 months
Myocardial Infarction
Time Frame: Index admission, 1 month, 6 months, 12 months
Cumulative incidence rate of myocardial infarction at each visit
Index admission, 1 month, 6 months, 12 months
All-cause death or Myocardial infarction
Time Frame: Index admission, 1 month, 6 months, 12 months
Cumulative incidence rate of all-cause death or myocardial infarction at each visit
Index admission, 1 month, 6 months, 12 months
Cardiac death or Myocardial infarction
Time Frame: Index admission, 1 month, 6 months, 12 months
umulative incidence rate of cardiac death or myocardial infarction at each visit
Index admission, 1 month, 6 months, 12 months
Target vessel revascularization
Time Frame: Index admission, 1 month, 6 months, 12 months
Cumulative incidence rate of target vessel revascularization at each visit
Index admission, 1 month, 6 months, 12 months
Target lesion revascularization
Time Frame: Index admission, 1 month, 6 months, 12 months
Cumulative incidence rate of target lesion revascularization at each visit
Index admission, 1 month, 6 months, 12 months
Stent thrombosis
Time Frame: Index admission, 1 month, 6 months, 12 months
Cumulative incidence rate of stent thrombosis at each visit
Index admission, 1 month, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Youngkeun Ahn, MD, Chonnam National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2017

Primary Completion (Actual)

March 18, 2021

Study Completion (Actual)

March 18, 2022

Study Registration Dates

First Submitted

March 27, 2021

First Submitted That Met QC Criteria

March 27, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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