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)
试验速览
- 阶段
- 不适用
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Incidence of malapposed and uncovered stent strut at 12±1 months in both DES groups
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Incidence of malapposed and uncovered stent strut at 12±1 months in both DES groups
时间窗: 12month
Incidence of malapposed and uncovered stent strut measured by OCT
次要结局
- Mean neointima thickness(12month)
- Percent neointima cross-sectional area(12month)
- Morphologic characteristics of neointima(12month)
研究者
Seung-Ho Hur
Professor of Internal Medicine
Keimyung University Dongsan Medical Center