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

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ClinicalTrials.gov Identifier: NCT02770651
Recruitment Status : Enrolling by invitation
First Posted : May 12, 2016
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Seung-Ho Hur, Keimyung University Dongsan Medical Center

Brief 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 polymer(Resolute Onyx™, Medtronic, Santa Rosa, CA, USA) implantation in patients with AMI at 12 months.

Condition or disease Intervention/treatment
Coronary Artery Disease Coronary Disease Myocardial Ischemia Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Heart Diseases Vascular Diseases Device: Everolimus-Eluting stent Device: Zotarolimus-Eluting stent

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).

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Study Type : Observational
Estimated Enrollment : 69 participants
Observational Model: Case-Control
Time Perspective: Prospective
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)
Study Start Date : May 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Optical Coherence Tomography
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 polymerversus zotarolimus-eluting stent (ZES) with permanent polymer implantation in patients with AMI at 12 months.
Device: Everolimus-Eluting stent
Everolimus-Eluting stent with bioabsorbable polymer
Other Name: Synergy™

Device: Zotarolimus-Eluting stent
Zotarolimus-Eluting stent with permanent polymer
Other Name: Resolute Onyx™




Primary Outcome Measures :
  1. Incidence of malapposed and uncovered stent strut at 12±1 months in both DES groups [ Time Frame: 12month ]
    Incidence of malapposed and uncovered stent strut measured by OCT


Secondary Outcome Measures :
  1. Percent neointima cross-sectional area [ Time Frame: 12month ]
    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)

  2. Mean neointima thickness [ Time Frame: 12month ]
    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)

  3. Morphologic characteristics of neointima [ Time Frame: 12month ]
    Morphologic characteristics of neointima measured by OCT(morphologic characteristics of neointima is one of fibrous, fibrocalcific, lipid-laden)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Acute myocardial infarction including ST-segment elevation myocardial infarction (STEMI) or non ST-segment elevation myocardial infarction (NSTEMI) treated with PCI
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770651


Locations
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Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of
Sponsors and Collaborators
Keimyung University Dongsan Medical Center
Investigators
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Principal Investigator: Seung-Ho Hur, Postdoctoral Keimyung University Dongsan Medical Center

Publications:

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Responsible Party: Seung-Ho Hur, Professor of Internal Medicine, Keimyung University Dongsan Medical Center
ClinicalTrials.gov Identifier: NCT02770651     History of Changes
Other Study ID Numbers: 2016-01-030
APPOSITION-AMI II ( Other Identifier: Keimyung University Dongsan Medical Center )
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: undecided
Keywords provided by Seung-Ho Hur, Keimyung University Dongsan Medical Center:
optical coherence tomography
everolimus-eluting stent
zotarolimus-eluting stent
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Ischemia
Cardiovascular Diseases
Pathologic Processes
Sirolimus
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents