NCT02486068进行中（未招募）不适用
ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of Restenosis Following Percutaneous Coronary Intervention in Patients at High Risk of Restenosis
European Cardiovascular Research Center87 个研究点 分布在 9 个国家目标入组 1,670 人开始时间: 2015年9月28日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,670
- 试验地点
- 87
- 主要终点
- non-inferiority of the everolimus-eluting bioresorbable scaffold (Absorb) to the everolimus eluting cobalt chromium metallic stent (Xience) in target lesion failure (TLF)
研究概览
简要总结
The primary objectives of this trial are:
In patients at high-risk for restenosis,
- To assess non-inferiority of the everolimus-eluting bioresorbable scaffold (BRS) to the everolimus eluting cobalt chromium metallic stent (EES) in target lesion failure (TLF) at 1 year
- To assess superiority of the BRS to the EES in TLF between 3 and 7 years
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (18-75 years old) with at least one of the followings:
- •High-risk characteristics for restenosis
- •Medically treated Diabetes (oral medication or insulin)
- •Multivessel disease of which more than one de-novo target lesion to be treated with the study scaffold/stent
- •Complex target lesion
- •Single de-novo target lesion satisfying at least one of the following:
- •Lesion length >28 mm
- •Small vessels: Target lesion reference vessel diameter between ≥2.5 mm and ≤2.75mm
- •Lesion with pre-existing total occlusion (pre-procedural TIMI = 0)
- •Bifurcation with single stent strategy
排除标准
- •Patients are excluded from this study if they have:
- •Age <18 years or >75 years
- •Known comorbidities which make patients unable to complete 7-years follow-up
- •Female of childbearing potential (and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy
- •Pregnant woman
- •Breastfeeding woman
- •Known intolerance to aspirin, heparin, PLLA, everolimus, contrast material
- •Cardiogenic Shock (Killip >2)
- •PCI with implantation of stents/scaffolds within previous 30 days.
- •Active bleeding or coagulopathy or patients at chronic anticoagulation therapy
- •Subject is currently participating in another clinical trial that has not yet completed its primary endpoint
- •Renal insufficiency (GFR <45 ml/min)
- •Life expectancy < 7 years
- •Known non-adherence to DAPT
- •Patients on oral anticoagulation therapy (including novel oral anticoagulant such as dabigatran, rivaroxaban, apixaban and edoxaban)
- •LVEF <30%
- •Patients at high bleeding risk who are not suitable for long-term DAPT
- •Following lesion characteristics:
- •Target lesion reference vessel diameter (RVD) < 2.5 and > 4 mm
- •STEMI with RVD of >3.5mm of the culprit target lesion
- •Target lesion with in-stent/scaffold thrombosis
- •Graft lesions as target lesions
- •Aorto-ostial lesion(s)
- •Left main lesion
- •Severe tortuosity of target vessel
- •In-scaffold restenosis
- •Bifurcation target lesion with intended 2 stent/scaffold strategy
- •Non-target lesion and target lesion in the same epicardial coronary artery (right coronary artery, left circumflex artery or left anterior descending artery)
研究组 & 干预措施
ABSORB scaffold
Experimental
Patient will undergoes elective or emergent percutaneous coronary intervention and will be treated with ABSORB scaffold.
干预措施: ABSORB scaffold (Device)
Xience
Active Comparator
Patient will undergoes elective or emergent percutaneous coronary intervention and will be treated with Xience Prime.
干预措施: Xience (Device)
结局指标
主要结局
non-inferiority of the everolimus-eluting bioresorbable scaffold (Absorb) to the everolimus eluting cobalt chromium metallic stent (Xience) in target lesion failure (TLF)
时间窗: 1 year
Composite of: * Cardiac death * Myocardial infarction (MI) in target vessel territory (SCAI consensus for periprocedural MI, 3rd universal definition for spontaneous or other MI) * Clinically Indicated Target lesion revascularization
次要结局
- superiority of the Absorb to the Xience in TLF between 3 and 7 years(5 years)
- Superiority of the Absorb to the Xience in TLF at 7 years(7 years)
- Superiority of the Absorb to the XIence in cumulative angina rate at 1 year(1 year)
研究者
研究点 (87)
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