Skip to main content
OpenTrials
Completed

NCT Number: NCT04825886

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gyeongsang National University Changwon Hospital, Changwon, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

zotarolimus-eluting stent

Device

Percutaneous coronary intervention using zotarolimus-eluting stent

Primary outcomes

  1. 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

Secondary outcomes

  1. All-cause death

    Time frame: Index admission, 1 month, 6 months, 12 months

    Cumulative incidence rate of all-cause death at each visit

  2. Cardiac death

    Time frame: Index admission, 1 month, 6 months, 12 months

    Cumulative incidence rate of cardiac death at each visit

  3. Myocardial Infarction

    Time frame: Index admission, 1 month, 6 months, 12 months

    Cumulative incidence rate of myocardial infarction at each visit

  4. 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

  5. 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

  6. Target vessel revascularization

    Time frame: Index admission, 1 month, 6 months, 12 months

    Cumulative incidence rate of target vessel revascularization at each visit

  7. Target lesion revascularization

    Time frame: Index admission, 1 month, 6 months, 12 months

    Cumulative incidence rate of target lesion revascularization at each visit

  8. Stent thrombosis

    Time frame: Index admission, 1 month, 6 months, 12 months

    Cumulative incidence rate of stent thrombosis at each visit

Sponsors and collaborators

Lead sponsor

Chonnam National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Apr 1, 2021
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.