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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Iran1 site
  • Shiraz University of Medical Sciences

    Shiraz, Fars, 713481433

Other trials in Iran

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.

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 groups in NCT06470529
Study groupRoleWhat they receive
PCIPost 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.

  1. 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.

  1. First posted24 Jun 2024
  2. Study start1 Mar 2019
  3. Primary completion1 Feb 2021
  4. Study completion1 Jul 2021

Resources

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
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

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.

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