Amsterdam Investigator-initiateD Absorb Strategy All-comers Trial (AIDA Trial): A Clinical Evaluation Comparing the Efficacy and Performance of ABSORB™ Everolimus Eluting Bioresorbable Vascular Scaffold Strategy Versus the XIENCE Family (XIENCE PRIME™ or XIENCE Xpedition™) Everolimus Eluting Coronary Stent Strategy in the Treatment of Coronary Lesions in Consecutive All-comers.
试验速览
- 阶段
- 不适用
- 入组人数
- 1,845
- 试验地点
- 6
- 主要终点
- Target Vessel Failure (TVF)
研究概览
简要总结
To evaluate the efficacy and performance in an all-comers contemporary population of the ABSORB bioresorbable vascular scaffolds (BVS) strategy versus the XIENCE family (XIENCE PRIME or XIENCE Xpedition) everolimus eluting coronary stent system in the treatment of coronary lesions.
详细描述
The AIDA trial is a prospective, randomized (1:1), active control, single blinded, four-center, all-comers, non-inferiority trial. A total of 1845 patients were enrolled. The study population includes both simple and complex lesions, as well as stable and acute coronary syndrome patients. The follow-up will continue for 5 years including clinical endpoint characteristics.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions and the Instructions for Use of the ABSORB BVS strategy and XIENCE family.
- •Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the ABSORB BVS strategy and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee.
排除标准
- •Subject is younger than 18 years of age
- •Subject has a true bifurcation lesion where a priori two scaffold/stent strategy is planned.
- •Unsuccessful predilation of one or more of the planned lesion to be treated.
- •Planned treatment of in-stent restenosis of a previously placed metallic stent.
- •Subject has one or more lesion planned to be treated with a scaffold/stent diameter size smaller than 2.5 mm or greater than 4.0 mm.
- •Subject has one or more lesion planned to be treated with a stent/scaffold length greater than 70 mm and/or overlapping of four or more scaffolds/stents.
- •Subject has known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel, prasugrel and ticagrelor, inclusive), everolimus, poly (L-lactide), poly (DL-lactide), cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
- •Subjects pregnant or nursing subjects and those who plan pregnancy in the period up to 2 years following index procedure. (Female subjects of child-bearing potential must have a negative pregnancy test done within 28 days prior to the index procedure and contraception must be used during participation in this trial)
- •Subjects with a limited life expectancy less than one year.
- •Subjects with factors that impede clinical follow-up (e.g. no fixed abode).
- •Subject is already participating in another clinical investigation that has not yet reached its primary endpoint.
- •Subject is belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff or sponsor staff) or subject unable to read or write.
研究组 & 干预措施
XIENCE™
XIENCE PRIME everolimus eluting coronary stent system and the XIENCE Xpedition everolimus eluting coronary stent system
干预措施: XIENCE™ (Device)
ABSORB BVS™
Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System
干预措施: ABSORB BVS™ (Device)
结局指标
主要结局
Target Vessel Failure (TVF)
时间窗: 2 years
The primary composite endpoint is the device-oriented composite of target vessel failure (TVF): * Cardiac death * Myocardial Infarction (MI) (unless clearly attributable to a non target vessel) * Target vessel revascularization
次要结局
- Device success(1 day)
- Target vessel failure (TVF)(30 days, and 1, 3, 4 and 5 years)
- Procedural success(1 day)
- Major adverse cardiac events(30 days, and 1, 2, 3, 4 and 5 years)
- All cause mortality(30 days, 1 year, 2, 3, 4 and 5 years)
- Target Lesion Revascularization (TLR)(30 days, 1 year, 2, 3, 4 and 5 years)
- Target lesion failure(30 days, and 1, 2, 3, 4 and 5 years)
- Target Vessel Revascularization (TVR)(30 days, 1 year, 2, 3, 4 and 5 years)
- Quality of Life Questionnaire (QOL)(1 year and 2 years)
- All revascularizations(5 year)
- Scaffold/Stent Thrombosis(30 days, 1, 2, 3, 4 and 5 years)
- Myocardial Infarction(30 days, 1, 2, 3, 4 and 5 years)
- Non-Target Vessel Revascularization (NTVR)(30 days, 1 year, 2, 3, 4 and 5 years)
- Seattle Angina Questionnaire (SAQ)(1 year and 2 years)
研究者
J.J. Wykrzykowska
J.J. Wykrzykowska, MD, PhD, Coordinating Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)