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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Coronary Artery Disease Coronary Disease Myocardial Ischemia Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Heart Diseases Vascular Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Everolimus-Eluting stent

Intervention Type DEVICE

Everolimus-Eluting stent with bioabsorbable polymer

Zotarolimus-Eluting stent

Intervention Type DEVICE

Zotarolimus-Eluting stent with permanent polymer

Interventions

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Everolimus-Eluting stent

Everolimus-Eluting stent with bioabsorbable polymer

Intervention Type DEVICE

Zotarolimus-Eluting stent

Zotarolimus-Eluting stent with permanent polymer

Intervention Type DEVICE

Other Intervention Names

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Synergy™ Resolute Onyx™

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No