Impact of Optical Coherence Tomography-guided versus Angiography-guided Stent Optimization on Post-Interventional Fractional Flow Reserve in Patients with Complex Coronary Artery Lesions

Chonnam National University Hospital0 个研究点目标入组 320 人开始时间: 待定最近更新: 2024年3月4日

试验速览

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•1)Patients >18 years old
•2)Patients with stable or unstable angina and complex coronary lesions*
•3)Patients who were indicated revascularization
•-Diameter stenosis >90% by angiography
•-Diameter stenosis with 50~90% with pre-interventional FFR =0.80
•4)Patients who underwent implantation of 2nd generation drug-eluting stent
•* Definitions of complex coronary lesions
•[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] PCI for unprotected left main (LM) disease (LM os, body, distal LM bifurcation including non-true bifurcation)
•[4] Long coronary lesions (implanted stent =38 mm in length)
•[5] Multi-vessel PCI (=2 major epicardial coronary arteries treated at one PCI session)
•[6] Multiple stents needed (=3 more stent per patient)
•[7] In-stent restenosis lesion as target lesion
•[8] Severely calcified lesion (encircling calcium in angiography)
•[9] Left anterior descending (LAD), left circumflex artery (LCX), and right coronary artery (RCA) ostial lesion

•1)Target lesions not amenable for PCI by operators’ decision
•2)Cardiogenic shock (Killip class IV) at presentation
•3)Less than TIMI 3 flow of target vessel after index procedure
•4)Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, Everolimus, Zotarolimus, Biolimus, or Sirolimus
•5)Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
•6)Renal insufficiency such that an additional contrast medium would be harmful for patient
•7)Recent ST-segment elevation myocardial infarction (STEMI)
•8)Inability to receive adenosine or nicorandil injection
•9)Pregnancy or breast feeding
•10)Non-cardiac co-morbid conditions are present with life expectancy <2 year or that may result in protocol non-compliance (per site investigator’s medical judgment)
•11)Unwillingness or inability to comply with the procedures described in this protocol

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