Prospective, Randomized, Controlled Arm Study Comparing the Coverage of the Zotarolimus-eluting Stent vs Bare Metal Stent Implanted in ST- Elevation Myocardial Infarction (STEMI).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Non inferiority OCT Number of uncovered Stent struts for Endeavor drug eluting stent vs Driver BMSbare metal stent
研究概览
简要总结
The objective of this study is to evaluate the completeness of struts coverage and vessel wall response (strut malapposition, neointima disomogeneities in texture) to the ENDEAVOR drug-eluting stent vs the DRIVER stent (bare metal stent of identical metallic platform) implanted for the treatment of the culprit lesion in ST-elevation acute myocardial infarction (STEMI). To investigate the completeness of the coverage as well as the number of uncovered stent struts per section (embedded, uncovered, malapposed) and the neointima texture, high resolution (~ 10-15 µm axial) intracoronary optical coherence tomography (OCT)will be used.
详细描述
Major concerns have been raised with regard to the safety of drug-eluting stents (DES) in patients with ST-elevation acute myocardial infarction (STEMI). Data from registry studies have suggested that implantation of DES during primary PCI could be associated with an increased risk for stent thrombosis, probably due to delayed arterial healing. Unlike first generation DES, zotarolimus-eluting stents seems to be associated with complete and uniform neointimal coverage. The objective of this prospective study is to measure the completeness of strut coverage and vessel wall response to the ENDEAVOR zotarolimus-eluting stent vs the DRIVER stent (bare metal stent of identical metallic platform) implanted in STEMI patients. Optical Coherence Tomography (OCT) that detects smaller degrees of stent strut coverage more accurately than IVUS will be used at 6 months follow-up. Intravascular ultrasound (IVUS) will be performed as per normal practice at any index procedures and at 6 months follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 MI with ST segment Elevation, within 12 hours from symptoms onset
- •Native coronary artery disease with >70% diameter stenosis (no prior stent implant, no prior brachytherapy)
- •Vessel size in between 2.5 and 3.75 mm
- •Signed patient informed consent
排除标准
- •Lesions in coronary artery bypass grafts
- •Significant left main disease
- •Killip class IV
- •Reecent major bleeding (6 months)
- •Renal failure with creatinine value > 2.5 mg/dl
- •Allergy to aspirin and or clopidogrel/ticlopidine
- •Patient in anticoagulant therapy
- •IMA due to a stent thrombosis
- •No suitable anatomy for OCT scan: (only ostial location, very tortuous anatomy, very distal or large vessels [≥ 3.75 mm in diameter])
结局指标
主要结局
Non inferiority OCT Number of uncovered Stent struts for Endeavor drug eluting stent vs Driver BMSbare metal stent
时间窗: 6 months
Non inferiority
次要结局
- In segment OCT neontimal volume(6 months)
- number of well apposed stent struts without neointima(6 months)
- number of malapposed stent struts without neointima(6 months)
- number of sections with > 30% uncovered struts/total struts(6 months)
- Number of sections with incomplete strut apposition(6 months)
- Adjudicated MACE(Death, re-MI, TLR) rate at 30 days and 6 months (non inferiority)(6 months)
研究者
Giulio Guagliumi
Interventional cardiologist
A.O. Ospedale Papa Giovanni XXIII