Randomized Controlled Trial of Intravascular Imaging Guidance versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention

Samsung Medical Center0 个研究点目标入组 1,620 人开始时间: 待定最近更新: 2020年11月3日

适应症

试验速览

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•?Subject age 19-85 years old
•?Coronary artery disease requiring PCI
•?Patients with complex lesion
•1) True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) with side branch =2.5mm size
•2) Chronic total occlusion (=3 months) as target lesion
•3) Unprotected LM disease PCI (LM os, body, distal LM bifurcation including non-true bifurcation)
•4) Lesion needed =2 more overlapping stents or lesion length =30mm by visual estimation
•5) Multi-vessel PCI (=2 vessels treated at one PCI session)
•6) Multiple stent needed (=3 more stent per patient)
•7) In-stent restenosis lesion as target lesion
•8) Severely calcified lesion (encircling calcium in angiography)

•?Target lesions not amenable for PCI by operators decision
•?Cardiogenic shock (Killip class IV) at presentation
•?Intolerance to Aspirin, Clopidogrel, Plasugrel, Ticagrelor, Heparin, Everolimus, Zotarolimus, Biolimus, or Sirolimus
•?Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
•?Pregnancy or breast feeding
•?Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator’s medical judgment)
•?Unwillingness or inability to comply with the procedures described in this protocol.

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