NL-OMON41656已完成不适用
Amsterdam Investigator-initiateD Absorb strategy all-comers trial - AIDA trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,790
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •o 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.
- •o Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the ABSORB BVS strategy and he/sheprovides written or in the event of STEMI oral informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee.
排除标准
- •o Subject is younger than 18 years of age
- •o Subject has a true bifurcation lesion where a priori two scaffold/stent strategy is planned.
- •o Unsuccessful predilation of one or more of the planned lesion to be treated.
- •o Planned treatment of in-stent restenosis of a previously placed metallic stent.
- •o 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.
- •o 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.
- •o 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.
- •o 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)
- •o Subjects with a limited life expectancy less than one year.
- •o Subjects with factors that impede clinical follow-up (e.g. no fixed abode).
- •o Subject is already participating in another clinical investigation that has not yet reached its primary endpoint.
- •o 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.
研究者
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