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Diabetes MellitusNCT05759676

Efficacy and Safety of Polymer-free Amphilimus-eluting Stent According to the Diabetes

An observational study of Diabetes Mellitus and Coronary Artery Disease, run by Korea University Anam Hospital at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Drug-eluting stents (DES) have been found to reduce the rate of stent restenosis compared to bare metal stents (BMS), but the first generation DES caused an increase in stent thrombosis. The second generation DES, including the Cre8Evo stent, has been designed to address these issues. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Diabetes Mellitus, Coronary Artery Disease
What is being tested?
Cre8™/Cre8™ EVO drug-eluting stent
Type of treatment
Medical device
How many people
1,800 participants
Where
1 siteSouth Korea
Study dates
9 Mar 2023to 31 Dec 2026
How long will I take part?
12 Months
Phase
Observational
Are there results?
Not yet: the study is under way

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: Patient with coronary artery disease who is undergoing percutaneous coronary intervention

Who may be able to join

  • Age 19 or older
  • Patients who agreed to the research protocol and clinical follow-up plan, voluntarily decided to participate in this study, and gave written consent to the consent form ③ Patients who underwent coronary angioplasty by inserting Cre8™ or Cre8™ EVO stent for coronary artery disease for a lesion confirmed within the last 1 month

Who cannot join

  • Patients with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, amphilimus, cobalt chrome, stainless steel nickel, 316L metal, and contrast media If it can be controlled by pheniramine and pheniramine, registration is possible, but if there is known anaphylaxis, it is excluded.)
  • Pregnant women, lactating women, or women of childbearing age who are planning to become pregnant during the study period ③ Patients who are planning surgery to stop antiplatelet drugs within 12 months from registration
  • Patients whose remaining life expectancy is expected to be less than 1 year
  • Patients who visited the hospital due to cardiogenic shock and are predicted to have a low survival rate based on medical judgment ⑥ Subjects participating in medical device randomization research ⑦ Patients who underwent surgery using a stent other than Cre8™/Cre8™ EVO at the time of registration

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

South Korea1 site, 1 recruiting

  • Korea University Anam Hospital

    Seoul, 136-705

    Soon Jun Hong, MD, PhD, +82-2-920-5625, psyche94@gmail.com

    Recruiting

Other trials in South Korea

About this study

Official title: A Prospective, Multicenter Observational Study of Efficacy and Safety of Polymer-free Amphilimus-eluting Stent (Cre8™/Cre8™ EVO) in Patients With Coronary Artery Disease According to the Presence of Diabetes Mellitus

Drug-eluting stents (DES) have been found to reduce the rate of stent restenosis compared to bare metal stents (BMS), but the first generation DES caused an increase in stent thrombosis. The second generation DES, including the Cre8Evo stent, has been designed to address these issues. The Cre8Evo stent is made of cobalt chromium and releases the drug amphilimus into the vessel wall, which is quickly absorbed and then lost, creating a BMS-like form. The Cre8Evo stent does not contain polymers and does not induce an inflammatory response. It inhibits cdk2 and RhoA, reducing the proliferation and migration of vascular smooth muscle cells. In diabetic patients, the Cre8Evo stent showed superior results in suppressing late proliferation compared to conventional DES. The Cre8Evo stent has been found to be safe and effective in clinical studies, and it has a superior effect in the clinical course of diabetic patients compared to other stents. The purpose of the study is to evaluate the effectiveness and safety of the Cre8Evo stent in actual clinical practice, specifically comparing outcomes in patients with and without diabetes.

Being tested
Cre8™/Cre8™ EVO drug-eluting stent
Medical subject headings
Diabetes Mellitus, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cre8™/Cre8™ EVO drug-eluting stentDevice

    Patient with CAD who undergoing PCI with Cre8™/Cre8™ EVO drug-eluting stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Target lesion failure(Device-oriented composite endpoints)

    composite of cardiac death, any myocardial infarction not clearly attributatble to a non-target vessel, and clinical indicated target lesion revascularization in patient with DM and non-DM

    Measured: 12 month

Secondary outcomes (11)

  1. patient-oriented composite endpoint

    composite of all-cause mortality, any myocardial infarction, and any revascularization in patient with DM and non-DM

    Measured: 12 month

  2. Incidence of all-cause mortality

    Incidence of all-cause mortality in patient with DM and non-DM

    Measured: 12 month

  3. Incidence of all-cause cardiac death

    Incidence of all-cause cardiac death in patient with DM and non-DM

    Measured: 12 month

  4. Incidence of all-cause non-cardiac death

    Incidence of all-cause non-cardiac death in patient with DM and non-DM

    Measured: 12 month

  5. Incidence of any myocardial infarction

    Incidence of any myocardial infarction in patient with DM and non-DM

    Measured: 12 month

  6. Incidence of any myocardial infarction not clearly attributatble to a non-target vessel

    Incidence of any myocardial infarction not clearly attributatble to a non-target vessel in patient with DM and non-DM

    Measured: 12 month

  7. Incidence of any revascularization

    Incidence of any revascularization in patient with DM and non-DM

    Measured: 12 month

  8. Incidence of target lesion revascularization

    Incidence of target lesion revascularization in patient with DM and non-DM

    Measured: 12 month

  9. Incidence of stent thrombosis

    Incidence of stent thrombosis in patient with DM and non-DM

    Measured: 12 month

  10. Lesion success rate

    less than 50% of residual stenosis after all procedure in patient with DM and non-DM

    Measured: the day of procedure

  11. Procedural success rate

    composite of less than 50% of residual stenosis after all procedure, no in-hospital event including death, MI, revascularization in patient with DM and non-DM

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2023
  2. Study start9 Mar 2023
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

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
Prospective
Enrolment
1,800 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05759676
Sponsor's protocol ID
CRE8DM
Status last verified
Apr 2024
First submitted
26 Feb 2023
Last updated
4 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The subject identification information used in the study will be coded and managed so that personal identification is impossible. Documents and materials related to this study will be stored in a locked place designated by the research director. In accordance with Article 15 of the Enforcement Rules of the Bioethics and Safety Act, research-related records are planned to be kept for 3 years from the time the research is completed, and documents that have passed the retention period will be destroyed according to the relevant grounds.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus and Coronary Artery Disease, run by Korea University Anam Hospital at 1 site 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 4 Apr 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 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target lesion failure(Device-oriented composite endpoints) (time frame: 12 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05759676.

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 4 Apr 2024.

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