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Coronary Artery DiseaseNCT02770651

Late Stent Strut Apposition and Coverage After Drug-Eluting Stent Implantation by OCT in Patients With AMI

An observational study of Coronary Artery Disease and Coronary Disease, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to evaluate the incidence of late incomplete stent apposition (ISA) and un-coverage by optical coherence tomography (OCT) following everolimus-eluting stent (EES) with bioabsorbable polymer (SYNERGY™, Boston Scientific,Nattick, MA, USA) versus zotarolimus-eluting stent (ZES) with permanent… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Everolimus-Eluting stent and Zotarolimus-Eluting stent
Type of treatment
Medical device
How many people
69 participants
Where
1 siteSouth Korea
Study dates
May 2016to Dec 2018
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Acute myocardial infarction including ST-segment elevation myocardial infarction (STEMI) or non ST-segment elevation myocardial infarction (NSTEMI) treated with PCI

Who may be able to join

  • Acute myocardial infarction including ST-segment elevation myocardial infarction (STEMI) or non ST-segment elevation myocardial infarction (NSTEMI) treated with PCI
  • Patient ≥ 18 years of age
  • Patient judged suitable to receive anti-platelet drugs of ASA and ticagrelor for at least 12 months after the procedure
  • The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic, OCT follow up and provides informed consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
  • culprit lesion

Who cannot join

  • The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, abciximab, aspirin, ticagrelor, everolimus, zotarolimus, polymer, platinum chromium, cobalt chromium, contrast media
  • Female of childbearing potential unless a pregnancy test is negative or who possibly plan to become pregnant any time after enrollment
  • Cardiogenic shock
  • Patient with left ventricular ejection fraction <30%
  • Patient with left main disease
  • Patient with In-stent restenosis (ISR) at target vessel (either bare metal stent or DES, non-target vessel ISR is permitted)
Show all 10Show fewer
  • Patient with impaired renal function (creatinine >2.0mg/dL)
  • Patient with inadequate OCT images quality due to severe calcification, vessel tortuosity and artifacts
  • bifucation lesion needs complex procedure with insert two or more Drug eluting stents.
  • lesion length >30mm

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Keimyung University Dongsan Medical Center

    Daegu

Other trials in South Korea

About this study

Official title: LAte Stent Strut APPosition and COverage After Drug-Eluting Stent ImplantaTIOn by Optical Coherence Tomography in PatieNts With Acute Myocardial Infarction II(APPOSITION-AMI II)

The purpose of this study is to evaluate the incidence of late incomplete stent apposition (ISA) and un-coverage by optical coherence tomography (OCT) following everolimus-eluting stent (EES) with bioabsorbable polymer (SYNERGY™, Boston Scientific,Nattick, MA, USA) versus zotarolimus-eluting stent (ZES) with permanent polymer(Resolute Onyx™, Medtronic, Santa Rosa, CA, USA) implantation in patients with AMI at 12 months.

Read the detailed description

It has been known that persistence of polymer may affect the late/very late safety and efficacy of drug eluting stent (DES) although polymer provides a reservoir for programmed drug release. Newer durable polymers may have enhanced biocompatibility and seem to be associated with improved clinical outcomes. However, they have still been incriminated in the occurrence of inflammation, neo-atherosclerosis, and thrombosis. Therefore, the investigators will evaluate the vascular tissue reaction after different kinds of DES implantation under the high thrombogenic circumstance of acute myocardial infarction (AMI).

Being tested
Everolimus-Eluting stent, Zotarolimus-Eluting stent
Keywords
optical coherence tomography, everolimus-eluting stent, zotarolimus-eluting stent
Medical subject headings
Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Arterial Occlusive Diseases, Arteriosclerosis, Cardiovascular Diseases, Heart Diseases, Vascular Diseases

What participants receive

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

  • Everolimus-Eluting stentDevice

    Also called Synergy™

    Everolimus-Eluting stent with bioabsorbable polymer

  • Zotarolimus-Eluting stentDevice

    Also called Resolute Onyx™

    Zotarolimus-Eluting stent with permanent polymer

Study groups in NCT02770651
Study groupRoleWhat they receive
Optical Coherence TomographyTo evaluate the incidence of late incomplete stent apposition (ISA) and un-coverage by optical coherence tomography (OCT) following everolimus-eluting stent (EES) with bioabsorbable polymerversus zotarolimus-eluting stent (ZES) with permanent polymer implantation in patients with AMI at 12 months.
Receives: Device: Everolimus-Eluting stent; Device: Zotarolimus-Eluting stent

What is being measured

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

  1. Incidence of malapposed and uncovered stent strut at 12±1 months in both DES groups

    Incidence of malapposed and uncovered stent strut measured by OCT

    Measured: 12month

Secondary outcomes (3)

  1. Percent neointima cross-sectional area

    By OCT, percentage neointima cross sectional area can be obtained by dividing the neointimal area by the stent area.(neointima cross-sectional area in mm²(Quadratmillimeter)/sec)

    Measured: 12month

  2. Mean neointima thickness

    By OCT, neointima thickness can be measured as distance from the endoluminal surface of the neointima to the stent strut.(mean neointima thickness in millimeter)

    Measured: 12month

  3. Morphologic characteristics of neointima

    Morphologic characteristics of neointima measured by OCT(morphologic characteristics of neointima is one of fibrous, fibrocalcific, lipid-laden)

    Measured: 12month

Timeline

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

  1. First posted12 May 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionJun 2018 (estimated)
  4. Study completionDec 2018 (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
Case-control
Time perspective
Prospective
Enrolment
69 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02770651
Sponsor's protocol ID
2016-01-030
Other IDs
APPOSITION-AMI II
Status last verified
Jan 2018
First submitted
1 May 2016
Last updated
25 Jan 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided: undecided

Publications

  • Qian J, Zhang YJ, Xu B, Yang YJ, Yan HB, Sun ZW, Zhao YL, Tang YD, Gao Z, Chen J, Cui JG, Mintz GS, Gao RL. Optical coherence tomography assessment of a PLGA-polymer with electro-grafting base layer versus a PLA-polymer sirolimus-eluting stent at three-month follow-up: the BuMA-OCT randomised trial. EuroIntervention. 2014 Nov;10(7):806-14. doi: 10.4244/EIJY14M07_17.

    PubMed 25033105

  • Gwon HC, Hahn JY, Park KW, Song YB, Chae IH, Lim DS, Han KR, Choi JH, Choi SH, Kang HJ, Koo BK, Ahn T, Yoon JH, Jeong MH, Hong TJ, Chung WY, Choi YJ, Hur SH, Kwon HM, Jeon DW, Kim BO, Park SH, Lee NH, Jeon HK, Jang Y, Kim HS. Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: the Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting (EXCELLENT) randomized, multicenter study. Circulation. 2012 Jan 24;125(3):505-13. doi: 10.1161/CIRCULATIONAHA.111.059022. Epub 2011 Dec 16.

    PubMed 22179532

  • Kim S, Kim JS, Shin DH, Kim BK, Ko YG, Choi D, Cho YK, Nam CW, Hur SH, Jang Y, Hong MK. Comparison of early strut coverage between zotarolimus- and everolimus-eluting stents using optical coherence tomography. Am J Cardiol. 2013 Jan 1;111(1):1-5. doi: 10.1016/j.amjcard.2012.08.037. Epub 2012 Oct 2.

    PubMed 23040589

  • Karjalainen PP, Varho V, Nammas W, Mikkelsson J, Pietila M, Ylitalo A, Airaksinen JK, Sia J, Nyman K, Biancari F, Kiviniemi T. Early neointimal coverage and vasodilator response following biodegradable polymer sirolimus-eluting vs. durable polymer zotarolimus-eluting stents in patients with acute coronary syndrome -HATTRICK-OCT trial. Circ J. 2015;79(2):360-7. doi: 10.1253/circj.CJ-14-1000. Epub 2014 Dec 15.

    PubMed 25502167

  • Lee CH, Lee S, Hwang J, Kim IC, Cho YK, Yoon HJ, Kim H, Nam CW, Hur SH. Late stent strut apposition and coverage after drug-eluting stent implantation by optical coherence tomography in patients with acute myocardial infarction. Coron Artery Dis. 2025 Nov 1;36(7):610-617. doi: 10.1097/MCA.0000000000001536. Epub 2025 Sep 24.

    PubMed 40421609

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Coronary Disease, run by Keimyung University Dongsan Medical Center 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 5 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: status not confirmed, as of the sponsor's last update on 25 Jan 2018. 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?

Results are not available in the source record.

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?

Incidence of malapposed and uncovered stent strut at 12±1 months in both DES groups (time frame: 12month). 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 NCT02770651, which also lists 5 linked publications.

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 25 Jan 2018.

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