Amsterdam Investigator-initiated Absorb trial the bifurcation strategy - AIDA bifurcation strategy

Academisch Medisch Centrum0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•o Subject is enrolled in the Amsterdam Investigator-InitiateD Absorb strategy trial
•o Subject has a bifurcation lesion involving a side-branch greater than 2 mm (excluding Medina class 0,0,1 where the is no main-branch involvement)
•o Subject must agree to undergo all clinical investigation plan-required follow-up visits and to undergo follow-up angiography and optical coherence tomography
•o Subject is able to verbally confirm understanding 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.

•o Subject is younger than 18 years of age
•o Subject is presenting with a STEMI
•o Subject has known hypersensitivity or contraindication to contrast that cannot be adequately pre-medicated.
•o Known renal insufficiency (eg. estimated Glomerular Filtration Rate (eGFR) <60mL/min/1.73m2 or serum creatinine level of >2.5mg/dL or subject on dialysis)
•o Subject is belonging to a vulnerable population (per investigator*s judgment, e.g., subordinate hospital staff) or subject unable to read or write.

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