title: Feasibility and safety of the second-generation, frequency domain optical coherence tomography (FD-OCT): a multicenter study.
abstract: OBJECTIVE
  This study sought to assess the effectiveness and safety of the second-generation frequency-domain optical coherence tomography (FD-OCT) system.
  
  
  BACKGROUND
  The second-generation FD-OCT was recently developed, with simplified imaging technique and faster acquisition time compared to the first-generation time-domain OCT. However, the safety and effectiveness of the FD-OCT has not been evaluated, and this study was conceived as a preapproval study for Food and Drug Administration clearance for clinical use in the United States.
  
  
  METHODS
  A total of 50 patients were enrolled from 3 institutions. Following stent implantation, the FD-OCT was performed with contrast injection through the guiding catheter to acquire pullback images with the pressure-triggered automatic pullback device. The primary endpoint was to achieve a median clear image length of more than 24 mm. Serious procedure-related or postprocedural adverse events (death, myocardial infarction, or ventricular arrhythmia) were recorded to assess safety of the device.
  
  
  RESULTS
  The primary endpoint of obtaining >24 mm of median clear image length (CIL) was achieved in 94% of the subjects (47 out of 50), with measured CIL of 43.2 mm. In 5 patients (10.6%), a second attempt was necessary due to suboptimal image quality of the first pullback. In 36 patients (76.6%), a full stent length was obtained during the first attempt. There were no serious procedure-related or postprocedural adverse events.
  
  
  CONCLUSIONS
  The new second-generation FD-OCT system provides fast and reliable resolution images of the coronary artery. The pullback can be safely performed over long segments of the artery without serious adverse events.
authors.affiliation: Cardiology Division, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts 02114, USA.
authors.forename: Joo Heung
authors.initials: JH
authors.lastname: Yoon
authors.forename: Luca
authors.initials: L
authors.lastname: Di Vito
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Moses
authors.forename: William F
authors.initials: WF
authors.lastname: Fearon
authors.forename: Alan C
authors.initials: AC
authors.lastname: Yeung
authors.forename: Shaosong
authors.initials: S
authors.lastname: Zhang
authors.forename: Hiram G
authors.initials: HG
authors.lastname: Bezerra
authors.forename: Marco A
authors.initials: MA
authors.lastname: Costa
authors.forename: Ik-Kyung
authors.initials: IK
authors.lastname: Jang
mesh_terms: D054058:Acute Coronary Syndrome / Q000000981:diagnostic imaging* / Q000628:therapy; D000368:Aged; D000787:Angina Pectoris / Q000000981:diagnostic imaging* / Q000628:therapy; D015906:Angioplasty, Balloon, Coronary; D017023:Coronary Angiography / Q000379:methods* / Q000639:trends; D018795:Device Approval; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007091:Image Processing, Computer-Assisted; D008297:Male; D008875:Middle Aged; D015203:Reproducibility of Results; D015607:Stents; D041623:Tomography, Optical Coherence / Q000295:instrumentation / Q000379:methods* / Q000639:trends