Coronary Artery DiseaseNCT04825886
Efficacy and Safety of ZotaRolimus-Eluting Coronary Stent System In Patients With Long Coronary Artery Disease
An observational study of Coronary Artery Disease and Myocardial Ischemia, run by Chonnam National University Hospital at 20 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease, Myocardial Ischemia, Coronary Disease
- What is being tested?
- Zotarolimus-Eluting Stent
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 20 sitesSouth Korea
- Study dates
- 28 Dec 2017to 18 Mar 2022
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Coronary artery disease
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- History of anaphylaxis to contrast agent
- Pregnancy and lactation
- Life expectancy < 1-year
- End stage renal disease on dialysis
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
South Korea20 sites
Gyeongsang National University Changwon Hospital
Changwon
Dankook University Hospital
Cheonan
Konkuk University Medical Center
Chungju
Daegu Catholic University Hospital
Daegu
Keimyung University Dongsan Medical Center
Daegu
Kyungpook National University Hospital
Daegu
Yeungnam University Medical Center
Daegu
Eulji Medical Center
Daejeon
Kongyang Univeristy Hospital
Daejeon
Chonnam National University Hospital
Gwangju
Chosun University Hospital
Gwangju
Wongkwang University Hospital
Iksan
Jeonbuk National University Hospital
Jeonju
Presbyterian Medical Center
Jeonju
Dong-A University Hospital
Pusan
Kosin University Gospel Hospital
Pusan
Paik Hospital
Pusan
Pusan National University Hospital
Pusan
Saint Carollo Hospital
Suncheon
Pusan National University Yangsan Hospital
Yangsan
About this study
Official 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
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.
Read the 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.
- Being tested
- Zotarolimus-Eluting Stent
- Keywords
- Coronary Artery Disease, Zotarolimus-Eluting Stent, Long Coronary Artery Disease, Target lesion failure
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zotarolimus-Eluting StentDevice
Percutaneous coronary intervention using zotarolimus-eluting stent
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion failure
Composite endpoint of clinically driven target lesion revascularization, myocardial infarction or cardiac death related to target vessel
Measured: Index admission to 12 months
Secondary outcomes (8)
All-cause death
Cumulative incidence rate of all-cause death at each visit
Measured: Index admission, 1 month, 6 months, 12 months
Cardiac death
Cumulative incidence rate of cardiac death at each visit
Measured: Index admission, 1 month, 6 months, 12 months
Myocardial Infarction
Cumulative incidence rate of myocardial infarction at each visit
Measured: Index admission, 1 month, 6 months, 12 months
All-cause death or Myocardial infarction
Cumulative incidence rate of all-cause death or myocardial infarction at each visit
Measured: Index admission, 1 month, 6 months, 12 months
Cardiac death or Myocardial infarction
umulative incidence rate of cardiac death or myocardial infarction at each visit
Measured: Index admission, 1 month, 6 months, 12 months
Target vessel revascularization
Cumulative incidence rate of target vessel revascularization at each visit
Measured: Index admission, 1 month, 6 months, 12 months
Target lesion revascularization
Cumulative incidence rate of target lesion revascularization at each visit
Measured: Index admission, 1 month, 6 months, 12 months
Stent thrombosis
Cumulative incidence rate of stent thrombosis at each visit
Measured: Index admission, 1 month, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start28 Dec 2017
- Primary completion18 Mar 2021
- Study completion18 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Chul Kim, Chonnam National University Hospital
- Investigators
- Youngkeun Ahn, MD, Principal investigator, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825886
- Sponsor's protocol ID
- CNUH-2017-319
- Status last verified
- Feb 2024
- First submitted
- 27 Mar 2021
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04825886
- Acronym / sponsor ID
- CNUH-2017-319
- Keywords
- Coronary Artery Disease, Zotarolimus-Eluting Stent, Long Coronary Artery Disease, Target lesion failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Study start
- 28 Dec 2017 (actual)
- Primary completion
- 18 Mar 2021 (actual)
- Study completion
- 18 Mar 2022 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Coronary artery disease
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zotarolimus-Eluting StentPercutaneous coronary intervention using zotarolimus-eluting stent | Device | – |
Primary outcome
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
8 secondary outcomes
All-cause death
Time frame: Index admission, 1 month, 6 months, 12 months
Cardiac death
Time frame: Index admission, 1 month, 6 months, 12 months
Myocardial Infarction
Time frame: Index admission, 1 month, 6 months, 12 months
All-cause death or Myocardial infarction
Time frame: Index admission, 1 month, 6 months, 12 months
Cardiac death or Myocardial infarction
Time frame: Index admission, 1 month, 6 months, 12 months
Target vessel revascularization
Time frame: Index admission, 1 month, 6 months, 12 months
Target lesion revascularization
Time frame: Index admission, 1 month, 6 months, 12 months
Stent thrombosis
Time frame: Index admission, 1 month, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Youngkeun Ahn, MD principal investigator
Chonnam National University Hospital
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Myocardial Ischemia, run by Chonnam National University Hospital at 20 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target lesion failure (time frame: Index admission to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.