Yoon Joo Heung, Di Vito Luca, Moses Jeffrey W, Fearon William F, Yeung Alan C, Zhang Shaosong, Bezerra Hiram G, Costa Marco A, Jang Ik-Kyung
Cardiology Division, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts 02114, USA.
J Invasive Cardiol. 2012 May;24(5):206-9.
This study sought to assess the effectiveness and safety of the second-generation frequency-domain optical coherence tomography (FD-OCT) system.
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.
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.
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.
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.
本研究旨在评估第二代频域光学相干断层扫描（FD-OCT）系统的有效性和安全性。
第二代FD-OCT最近已开发出来，与第一代时域OCT相比，其成像技术更简化，采集时间更快。然而，FD-OCT的安全性和有效性尚未得到评估，本研究被设想为一项用于美国食品药品监督管理局批准其临床使用的预批准研究。
从3个机构共招募了50名患者。在支架植入后，通过引导导管注入造影剂，使用压力触发自动回撤装置进行FD-OCT检查以获取回撤图像。主要终点是获得中位清晰图像长度超过24毫米。记录与手术相关的严重或术后不良事件（死亡、心肌梗死或室性心律失常）以评估该设备的安全性。
94%的受试者（50名中的47名）达到了获得中位清晰图像长度（CIL）>24毫米的主要终点，测量的CIL为43.2毫米。5名患者（10.6%）因首次回撤图像质量欠佳而需要进行第二次尝试。36名患者（76.6%）在首次尝试时获得了完整的支架长度。没有与手术相关的严重或术后不良事件。
新型第二代FD-OCT系统可提供快速且可靠的冠状动脉分辨率图像。在动脉的长节段上可以安全地进行回撤操作，而不会发生严重不良事件。
