微創心脈醫(yī)療科(kē)技(jì )（上海）有(yǒu)限公(gōng)司“Castor®分(fēn)支型主動脈覆膜支架及輸送系統”（以下簡稱“Castor®分(fēn)支型支架”）于2017年6月獲得國(guó)家食品藥品監督管理(lǐ)總局（CFDA）頒發的注冊證。近日，景在平教授及其團隊成功應用(yòng)Castor®分(fēn)支型支架治療主動脈夾層一例。

患者男性，76歲，術前CTA顯示破口雖不明顯但緊貼LSA，臨床診斷為(wèi)主動脈夾層。用(yòng)Endosize軟件評估後顯示，LCCA-LSA長(cháng)度為(wèi)5mm，LSA錨定區(qū)遠(yuǎn)端有(yǒu)一明顯折角。

手術難點：

1. 破口緊貼LSA根部，需要将錨定區(qū)延長(cháng)至LSA近端。

2. LCCA與LSA間長(cháng)度5mm，需要支架精(jīng)确定位，否則有(yǒu)覆蓋LCCA的風險。

手術方案：

景教授在充分(fēn)評估上述手術難點後，決定選用(yòng)Castor®分(fēn)支型支架，理(lǐ)由如下：

1. Castor®分(fēn)支型支架可(kě)以治療破口緊貼LSA的主動脈夾層，拓展近端錨定區(qū)。

2. Castor®分(fēn)支型支架的分(fēn)支後移長(cháng)度有(yǒu)5~30mm多(duō)種選擇，适應不同的血管解剖情況。本例中(zhōng)選擇分(fēn)支後移5mm的規格，即可(kě)重建LSA的同時，不影響LCCA血流。

手術過程：

首先經股動脈進行術前造影。造影顯示，近端錨定區(qū)直徑29mm，因此選擇近端直徑30mm，錐度6mm的Castor®分(fēn)支型支架。按照标準操作(zuò)流程，建立分(fēn)支導絲通道後，導入Castor®輸送系統并釋放。

術後造影顯示，Castor®分(fēn)支型支架定位精(jīng)準，無移位；支架近端三重小(xiǎo)波段密封性能(néng)良好，無内漏；LCCA和LSA血流均通暢；夾層破口被完全隔絕，手術取得圓滿成功。

微創®心脈“Castor®分(fēn)支型主動脈覆膜支架及輸送系統”6個月随訪結果于2015年1月30日在Vascular News上發表。這是全球首個應用(yòng)于人體(tǐ)的分(fēn)支支架多(duō)中(zhōng)心臨床試驗。

Castor®覆膜支架6個月随訪數據證明了該款産(chǎn)品治療胸主動脈夾層的臨床安(ān)全性和有(yǒu)效性。臨床試驗達到了主要臨床終點，臨床植入技(jì )術成功率為(wèi)98.6％。六個月随訪期間無新(xīn)增分(fēn)支動脈閉塞；6個月卒中(zhōng)發生率為(wèi)2/70，與器械無關；有(yǒu)2例與器械相關的不良事件，1例内漏和1例由于夾層遠(yuǎn)端發展導緻的2次介入。

Castor®覆膜支架是一款用(yòng)于腔内治療近主動脈弓的胸主動脈夾層的分(fēn)支型支架。Castor®覆膜支架用(yòng)于完全腔内治療累及左鎖骨下動脈，或破口與左鎖骨下動脈距離<15mm的胸主動脈夾層。主體(tǐ)加分(fēn)支的一體(tǐ)式設計能(néng)夠安(ān)全有(yǒu)效地治療累及弓部的夾層患者，微創安(ān)全、手術效果更好。

景在平教授表示：“Castor®分(fēn)支型支架的設計理(lǐ)念在全球都是領先的，這款産(chǎn)品使臨床醫(yī)生可(kě)以運用(yòng)完全腔内的技(jì )術，通過一款覆膜支架來修複累及主動脈弓部區(qū)域的夾層，同時維持弓上分(fēn)支動脈的自然血運。”

以下為(wèi)在Vascular News上發表的原文(wén)：

MicroPort® reports six-month follow-up data of Castor® Branched Aortic Stent Graft System

Fri Jan 30

Data from a clinical trial assessing the safety and efficacy of the Castor® Branched Aortic Stent-Graft System for the treatment of thoracic dissection has been released by MicroPort®, the device’s manufacturer.

Thoracic aortic dissections often involve or lie in close proximity to the left subclavian artery. In order to seek relatively healthy and sufficient landing zone, the left subclavian artery ostium is often covered during TEVAR with or without concomitant subclavian artery revascularisation. However, subclavian occlusion can cause hand and upper limb ischaemia, subclavian steal syndrome, and spinal cord ischaemia. Although it is possible to preserve the left subclavian artery through hybrid technique, chimney technique, or fenestration, all these methods have inherent deficiencies especially endoleak, chiminey graft occlusion, device kink, etc. Therefore, an easy-to-use unibody branched stent graft has become key to solve these clinical issues, the company says.

According to MicroPort®, Castor® is designed for an entirely endovascular treatment of thoracic dissection encroaching the left subclavian artery or the original tear located within 15mm distal to the left subclavian artery. Castor® employs an easy-to-use unibody design, including a main body and a left subclavian branch graft to avoid type III endoleaks. Zhonghua Li, vice president of MicroPort® Endovascular, said: “The key design of Castor is how to safely and accurately place the branch stent in the target artery, which is ensured by a unique two-layer out-sheath design and wire release mechanism. Adjustment of the direction of the stent graft can be performed accurately and safely under the protection of two middle soft sheaths for main body and branched stent grafts. A full deployment of the stent graft is conducted through a safe wire release mechanism.

Six-month data of the CASTOR® trial from 73 patients demonstrate safety and efficacy of the branched aortic stent graft system for the treatment of thoracic dissections. Conducted at 11 centres in China, the trial met its primary efficacy endpoint by achieving 98.6% technical success with two occlusions of the left subclavian artery for operational reasons. No further branch artery occlusions were observed during six-month follow-up. The six-month stroke rate is 2/70, which was not device related. There are two device-related severe adverse events, including one endoleaks and one reintervention due to distal development of the dissection. The dissection-related mortality rate was 2/73, and the all-cause mortality was 4/73.

Zaiping Jing, chief of Vascular Surgery Department of the 2nd Military Medical University-Changhai Hospital, served as the national principal investigator for the CASTOR® trial, and Qingsheng Lu, from the same hospital, worked as a major operator for CASTOR® trial. They said: “The Castor® system is the leading product around the world which allows physicians to safely treat aortic aneurysms or dissections near the aortic arch while maintaining blood flow to all branch vessels using an entirely endovascular approach.”