Coronary Artery DiseaseNCT06470529
MACE in Different Drug-Eluting Stents
An observational study of Coronary Artery Disease and Stent Restenosis, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
In this retrospective cohort study, all patients from Iranian registry were recruited and follow up after 5 years were recorded for MACE, and its relation to type and demographic data were evaluated Read more about this study
- Who is it for?
- Ages 36 to 82 years
- Conditions the study is for
- Coronary Artery Disease, Stent Restenosis
- What is being tested?
- drug eluting stents
- Type of treatment
- Medical device
- How many people
- 4,159 participants
- Where
- 1 siteIran
- Study dates
- 1 Mar 2019to 1 Jul 2021
- How long will I take part?
- 5 Years
- 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 36 to 82 years
- All sexes
- Adult, Older adult
Study population: Patients all around the Iran, from 40 hospitals, who undergone PCI as elective or emergency patients
Who may be able to join
- Patients with coronary angioplasty who received at least one type of DES
Who cannot join
- Patients who received multiple types of stents
- Patients who need emergency operation post PCI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Incidence of Cardiovascular Events Among Different Drug-Eluting Stent Types
In this retrospective cohort study, all patients from Iranian registry were recruited and follow up after 5 years were recorded for MACE, and its relation to type and demographic data were evaluated
Read the detailed description
This retrospective cohort study involved 4,438 individuals who received a PCI from March 2019 to February 2021. Data was obtained from the Iranian Network of Cardiovascular Research Registry ( which registered post PCI patients all around Iran in more than 40 public and private hospitals) and the database of Professor Kojuri Cardiology Clinic (Niyayesh St., Shiraz, Iran, www.kojuriclinic.com). After each procedure, expert cardiologists recorded baseline demographic data, prior medical history, angiography, and angioplasty reports.
Demographic data such as age, gender, body mass index (BMI), family history of CAD, prior CAD history, hypertension (HTN), diabetes mellitus (DM), hyperlipidemia (HLP), and kidney diseases were obtained from the database. Data on the prevalence of cigarette smoking, opium addiction, and alcohol addiction were collected. Additionally, information on clinical manifestations of the disease, including stable angina, unstable angina, ST-elevation myocardial infarction (STEMI), and non-ST elevation myocardial infarction (NSTEMI), was extracted.
According to the American Heart Association (AHA), stage 1 hypertension is defined as a systolic blood pressure of 130-139 mmHg or diastolic blood pressure of 80-89 mmHg ; Hypertension was defined as stage 1 or higher blood pressure. DM was defined according to The American Diabetes Association as having a hemoglobin A1c level of at least 6.5%, a fasting plasma glucose (FPG) level of 126 mg/dl or higher, an oral glucose tolerance test (OGTT) level of 200 mg/dl or greater, or a random plasma glucose level of 200 mg/dl or above . For defining dyslipidemia, based on the 2019 AHA guideline, a low-density lipoprotein cholesterol (LDL-C) level exceeding 160 mg/dl or a non-high-density lipoprotein cholesterol (non-HDL-C) over 190 mg/dl were considered . Individuals with ≤1 month of smoking cessation were considered current smokers .
Angiography and angioplasty data Angiography and angioplasty data were gathered, including the type and location of coronary artery lesions and the type, location, size, diameter, and number of stents. Drug-eluting stents encompass a variety of types, notably the biolimus-eluting stent (BES), amphilimus-eluting stent (AES), SES, ZES, PES, and EES. Within the BES category, a notable example is the BioMatrix™ stent, while SES includes options like BioMimeTM, Orsiro®, Cre8, SUPRAFLEX, ULTIMASTERTM, and Coroflex® ISAR. ZES variants include the Resolute Onyx™ and Resolute Integrity™ stents, whereas EES comprises options such as Promus PREMIER, Promus Element™, and XIENCE™. Polymer-coated drug-eluting stents (PC-DES) include BioMatrix™, BioMimeTM, Orsiro®, SUPRAFLEX, ULTIMASTERTM, Resolute Onyx™, Resolute Integrity™, Promus PREMIER, Promus Element™, and XIENCE™. Conversely, polymer-free drug-eluting stents (PF-DES) are exemplified by Cre8 and Coroflex® ISAR. Regarding generational classification, the first generation includes BioMimeTM, Orsiro®, Cre8, SUPRAFLEX, ULTIMASTERTM, and Coroflex® ISAR. Notable second-generation members are Promus PREMIER, Promus Element, and XIENCE™, alongside Resolute Onyx™ and Resolute Integrity™. Finally, the BioMatrix™ stent represents the third generation.
Data of ballooning, including predilatation, postdilatation, and the number of balloons used were collected. Different angioplasty techniques, including kissing and overlapping were collected .Coronary legions were classified according to the ACC/AHA classification: type A: <10 mm, non-angulated, smooth, little calcification, not totally occlusive, not ostial, no major branch involvement, no thrombus; type B: 10-20 mm, eccentric, moderately tortuous, 45-90º, irregular, moderate to heavy calcification, ostial, bifurcation lesions, some thrombus (subcategories: B1: one characteristic; B2: two or more characteristics), and type C: diffuse, extremely angulated, >90º, inability to protect major side branch, degenerated vein graft .
Follow-up Patients were contacted by phone to explain the study plans and obtain informed consent. They were asked about MACEs occurring within two years following angioplasty, which includes myocardial infarction, acute heart failure, stroke, and death from cardiac diseases, as well as any revascularization. Additionally, the date of MACE occurrence after angioplasty was recorded, and information on non-cardiac-related deaths was collected.
- Conditions
- Coronary Artery Disease, Stent Restenosis
- Being tested
- drug eluting stents
- Keywords
- Percutaneous coronary intervention, Major adverse coronary events (MACE), drug eluting stents
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug eluting stentsDevice
different types of drug eluting stents
| Study group | Role | What they receive |
|---|---|---|
| PCI | Post PCI patients with drug eluting stents Receives: Device: drug eluting stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse coronary events
Total sum of Myocardial infarction (MI), Hospital admission, Death, reoperation or re PCI,
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start1 Mar 2019
- Primary completion1 Feb 2021
- Study completion1 Jul 2021
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
- Cross-sectional
- Enrolment
- 4,159 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javad Kojuri, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470529
- Sponsor's protocol ID
- IR.SUMS.MED.RED.1402.409
- Status last verified
- Jun 2024
- First submitted
- 17 Jun 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data was available based on rational request
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Incidence of Cardiovascular Events Among Different Drug-Eluting Stent Types
- ClinicalTrials.gov ID
- NCT06470529
- Acronym / sponsor ID
- IR.SUMS.MED.RED.1402.409
- Conditions
- Coronary Artery Disease, Stent Restenosis
- Keywords
- Percutaneous coronary intervention, Major adverse coronary events (MACE), drug eluting stents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,159 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 24 Jun 2024 (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.
In this retrospective cohort study, all patients from Iranian registry were recruited and follow up after 5 years were recorded for MACE, and its relation to type and demographic data were evaluated
Detailed description
This retrospective cohort study involved 4,438 individuals who received a PCI from March 2019 to February 2021. Data was obtained from the Iranian Network of Cardiovascular Research Registry ( which registered post PCI patients all around Iran in more than 40 public and private hospitals) and the database of Professor Kojuri Cardiology Clinic (Niyayesh St., Shiraz, Iran, www.kojuriclinic.com). After each procedure, expert cardiologists recorded baseline demographic data, prior medical history, angiography, and angioplasty reports.
Demographic data such as age, gender, body mass index (BMI), family history of CAD, prior CAD history, hypertension (HTN), diabetes mellitus (DM), hyperlipidemia (HLP), and kidney diseases were obtained from the database. Data on the prevalence of cigarette smoking, opium addiction, and alcohol addiction were collected. Additionally, information on clinical manifestations of the disease, including stable angina, unstable angina, ST-elevation myocardial infarction (STEMI), and non-ST elevation myocardial infarction (NSTEMI), was extracted.
According to the American Heart Association (AHA), stage 1 hypertension is defined as a systolic blood pressure of 130-139 mmHg or diastolic blood pressure of 80-89 mmHg ; Hypertension was defined as stage 1 or higher blood pressure. DM was defined according to The American Diabetes Association as having a hemoglobin A1c level of at least 6.5%, a fasting plasma glucose (FPG) level of 126 mg/dl or higher, an oral glucose tolerance test (OGTT) level of 200 mg/dl or greater, or a random plasma glucose level of 200 mg/dl or above . For defining dyslipidemia, based on the 2019 AHA guideline, a low-density lipoprotein cholesterol (LDL-C) level exceeding 160 mg/dl or a non-high-density lipoprotein cholesterol (non-HDL-C) over 190 mg/dl were considered . Individuals with ≤1 month of smoking cessation were considered current smokers .
Angiography and angioplasty data Angiography and angioplasty data were gathered, including the type and location of coronary artery lesions and the type, location, size, diameter, and number of stents. Drug-eluting stents encompass a variety of types, notably the biolimus-eluting stent (BES), amphilimus-eluting stent (AES), SES, ZES, PES, and EES. Within the BES category, a notable example is the BioMatrix™ stent, while SES includes options like BioMimeTM, Orsiro®, Cre8, SUPRAFLEX, ULTIMASTERTM, and Coroflex® ISAR. ZES variants include the Resolute Onyx™ and Resolute Integrity™ stents, whereas EES comprises options such as Promus PREMIER, Promus Element™, and XIENCE™. Polymer-coated drug-eluting stents (PC-DES) include BioMatrix™, BioMimeTM, Orsiro®, SUPRAFLEX, ULTIMASTERTM, Resolute Onyx™, Resolute Integrity™, Promus PREMIER, Promus Element™, and XIENCE™. Conversely, polymer-free drug-eluting stents (PF-DES) are exemplified by Cre8 and Coroflex® ISAR. Regarding generational classification, the first generation includes BioMimeTM, Orsiro®, Cre8, SUPRAFLEX, ULTIMASTERTM, and Coroflex® ISAR. Notable second-generation members are Promus PREMIER, Promus Element, and XIENCE™, alongside Resolute Onyx™ and Resolute Integrity™. Finally, the BioMatrix™ stent represents the third generation.
Data of ballooning, including predilatation, postdilatation, and the number of balloons used were collected. Different angioplasty techniques, including kissing and overlapping were collected .Coronary legions were classified according to the ACC/AHA classification: type A: <10 mm, non-angulated, smooth, little calcification, not totally occlusive, not ostial, no major branch involvement, no thrombus; type B: 10-20 mm, eccentric, moderately tortuous, 45-90º, irregular, moderate to heavy calcification, ostial, bifurcation lesions, some thrombus (subcategories: B1: one characteristic; B2: two or more characteristics), and type C: diffuse, extremely angulated, >90º, inability to protect major side branch, degenerated vein graft .
Follow-up Patients were contacted by phone to explain the study plans and obtain informed consent. They were asked about MACEs occurring within two years following angioplasty, which includes myocardial infarction, acute heart failure, stroke, and death from cardiac diseases, as well as any revascularization. Additionally, the date of MACE occurrence after angioplasty was recorded, and information on non-cardiac-related deaths was collected.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCI | – | Device: drug eluting stentsPost PCI patients with drug eluting stents |
Who may qualify
- Ages
- 36 to 82 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients all around the Iran, from 40 hospitals, who undergone PCI as elective or emergency patients
Key inclusion criteria (1 listed)
- Patients with coronary angioplasty who received at least one type of DES
Key exclusion criteria (2 listed)
- Patients who received multiple types of stents
- Patients who need emergency operation post PCI
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 |
|---|---|---|
| drug eluting stentsdifferent types of drug eluting stents | Device | PCI |
Primary outcome
Major adverse coronary events
Time frame: 5 years
Total sum of Myocardial infarction (MI), Hospital admission, Death, reoperation or re PCI,
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 27 Jun 2024.
- Individual participant dataSharing planned: No. Data was available based on rational request
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Stent Restenosis, run by Shiraz University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 2 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 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. 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?
Major adverse coronary events (time frame: 5 years). 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 27 Jun 2024.