Percutaneous Coronary Intervention With the ANgiolite Drug-Eluting Stent: an Optical CoHerence TOmogRaphy Study. The ANCHOR Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Neo-intimal coverage
研究概览
简要总结
The purpose of this study is to perform a first-in-man assessment of feasibility, exploratory efficacy and clinical performance of the novel Angiolite drug-eluting stent (iVascular, Barcelona, Spain) utilizing intracoronary optical coherence tomography (OCT).
详细描述
This is a prospective registry including patient scheduled for a clinically-indicated percutaneous coronary intervention (PCI) of a de novo epicardial lesion with indication for drug-eluting stent implantation. Following study enrolment and PCI/stent with the Angiolite DES, patients will be scheduled for follow-up surveillance coronary angiography and OCT with the C7-XRTM Fourier Domain OCT system with C7 DragonflyTM catheter (St Jude Medical, Minneapolis, MN) or with the Terumo LunawayTM OCT system with fastview catheter (Terumo Medical Corporation, Tokyo, Japan). An adaptive design component of the study will randomize patients to either 3-month or 6-month angio/OCT follow-up. Clinical follow-up will occur at 30 days, 3 months, 6 months, 12 months and 24 months post PCI.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for clinically-indicated PCI of a de nove epicardial lesion, including those with chronic stable angina, ACS (defined as NSTEMI or ACS with negative cardiac enzymes) or in the setting of elective PCI.
- •Indication for DES implantation
- •Target lesion must have visually estimated stenosis ≥50% and one of the following: stenosis ≥70% or evidence of ischemia
- •Strong preference for single stent coverage per lesion, but if unexpected clinically indicated second stent placement with overlap is needed, these patients will not be excluded from optical coherence tomographic follow-up
- •Target lesion, if possible, should be predilated/pretreated
排除标准
- •Age >85 years
- •Acute ST segment elevation MI (STEMI)
- •Cardiogenic shock
- •Known left ventricular ejection fraction <30%
- •Contraindication for dual antiplatelet therapy (DAPT) for at least 6-month duration
- •Iodinated contrast allergy
- •Renal impairment with serum creatinine >2.0 mg/dL
- •Anticipated medical non-compliance
- •Life-expectancy <12 months
- •Chronic total occlusion (CTO) in the target vessel
- •Bifurcation lesion requiring a two-stent strategy
- •In-stent restenosis
- •Severe lesion/segment angulation/tortuosity
- •Severe vessel/lesion calcification
- •Simultaneous PCI within the same or different vessel during the same procedure
- •Lesion unsuitable for OCT (proximal lesions <10 mm from ostium of left main or right coronary arteries)
- •Lesion length >18 mm
- •Stent length >24 mm
- •Stent diameter ≤2.5 mm and > 4.0 mm
- •Unprotected left main coronary artery disease (≥50% diameter stenosis)
- •>1 lesion
- •Planned use of 2 overlapping stents
研究组 & 干预措施
Angiolite stent - 3-month angiogram/OCT
Patients scheduled for PCI (and whot meet pre-specified inlcusion criteria) are enrolled to receive the Angiolite DES. They will undergo a scheduled repeat coronary angiogram and OCT evaluation at 3-month post index PCI.
干预措施: Angiolite stent (Device)
Angiolite stent - 6-month angiogram/OCT
Patients scheduled for PCI (and whot meet pre-specified inlcusion criteria) are enrolled to receive the Angiolite DES. They will undergo a scheduled repeat coronary angiogram and OCT evaluation at 6-month post index PCI.
干预措施: Angiolite stent (Device)
结局指标
主要结局
Neo-intimal coverage
时间窗: 6-month
Strut-based analysis: % of covered struts. Cross-sectional analysis: number of cross-sections with RUTTS (Rate of uncovered to total number of struts) score\>30%. Measured by an independant OCT laboratory
Neo-intimal obstruction
时间窗: 6-month
Strut-based analysis: mean neointimal thickness (µm). Cross-sectional analysis: neointimal volume obstruction (%). Measured by an independant OCT laboratory
次要结局
- Neo-intimal coverage(3-month)
- Neo-intimal obstruction(3-month)
- Apposition(3- and 6-month)
- In-stent angiographic late lumen in mm(6-month)
- In-stent and in-segment restenosis(6-month)
- CV death(6-month and 1-year)
- Myocardial infarction(Peri-procedural, spontaneous)
- Target-lesion revascularization(24 months)
- Binary restenosis(24 months)
研究者
Josep Rodes-Cabau
MD
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec