近日，微創心脈醫(yī)療科(kē)技(jì )（上海）有限公司（以下簡稱“微創心脈”）宣布已有18名患者入組Minos™ Ultra-low profile腹主動脈覆膜支架系統上市前臨床研究，該臨床研究用(yòng)于評估Minos™ Ultra-low profile腹主動脈覆膜支架系統治療腎下型腹主動脈瘤（AAA）的臨床安(ān)全性和有效性。

Minos臨床研究是一項多(duō)中心、前瞻性、非随機臨床試驗，将在中國(guó)的15個中心入組130例AAA患者。

本次臨床試驗主要研究者－上海複旦大學(xué)附屬中山醫(yī)院血管外科(kē)主任符偉國(guó)教授表示：“就目前而言，Minos™”覆膜支架的密封性能(néng)尤其出色，能(néng)有效地隔絕瘤體(tǐ)，而輸送器的超低profile設計使術者能(néng)為(wèi)更多(duō)患者開展微創傷的腹主動脈瘤支架型腔内修複術（EVAR），尤其是入路血管較細，原本不适合接受EVAR術的患者。

Minos™覆膜支架的裸支架上帶有激光一體(tǐ)雕刻而成的倒鈎，單絲編織而成的分(fēn)支支架兼顧柔順性和支撐性，覆膜支架整體(tǐ)穩定錨定于腎下腹主動脈和雙側髂動脈，重塑血流通道，有效而持久地隔絕動脈瘤。

Minos™覆膜支架系統将輸送器的外徑降低到14~16F，将EVAR适應症擴展到入路動脈狹窄而扭曲的患者，尤其是女性患者，而目前中國(guó)市場上腹主動脈支架系統的輸送器外徑均在18~24F之間。因此Minos™ Ultra-low profile腹主動脈覆膜支架系統的超低profile的特性是EVAR領域的一項重要突破，為(wèi)患者和術者提供了更微創的治療方法和更穩定持久的治療效果。

以下為(wèi)在Vascular News上發表的原文(wén)：

MicroPort Endovascular begins Minos abdominal aortic stent graft pre-market study

Mon Mar 30, 2015

MicroPort Endovascular has announced that18 patients have now been enrolled in a pre-market clinical study to assess theefficacy and safety of the company’s Minos ultra-low profile abdominal aorticstent graft system to treat infrarenal abdominal aortic aneurysms.

The pre-market clinical study is amulticentre, open-label, prospective, non-randomised study that will enrol upto 130 abdominal aortic aneurysm patients in 15 centres in China.

“Up until now, the Minos system has had an especially effectivesealing effect”, said the study’s principle investigator, Weiguo Fu, head ofthe Department of Endovascular Surgery at Fudan University Zhongshan Hospitalin Shanghai, China. “Its ultra-low profile design allows physicians to employthis less invasive procedure for many patients, especially those with smallervasculature who might otherwise be ineligible for endovascular aneurysmrepair.”

The stent graft of the Minos systemfeatures laser-cut hooks on the bare stent and strong but flexible limbsachieving a stable and upright position in the aorta, in order to reinforce thelower part of the aorta and to effectively exclude an aneurysm.

The system is indicated for endovasculartreatment of abdominal aortic aneurysms, with the outer diameter of theintegrated delivery system ranging from 14–16 French. This feature has expandedendovascular aneurysm repair to patients with small or tortuous femoral or iliacarteries, which is especially common in female patients. Existing endovascularaneurysm repair devices in China have system profiles ranging from 18–24French. MicroPort believes that the “ultra-low” profile nature of the Minossystem represents an innovation in the field, providing patients and physicianswith a less invasive treatment approach and a more durable efficacy for thetreatment of abdominal aortic aneurysms.