Objective: To examine the safety and effectiveness of a new stent graft system for endovascular repair of abdominal aortic aneurysm(AAA). Methods: This is a prospective,multi-center,single-arm clinical trial. The patients with AAA treated with a new stent graft system were enrolled at 21 centers from September 2018 to September 2019 in China. Follow-up was performed before discharge, and at 30, 180, 360 days after operation, respectively. The primary safety endpoint was the incidence of major adverse events(MAE) within 30 days. The primary efficacy endpoint was the success rate of AAA treatment at 360 days. Secondary safety endpoints were the incidence of perioperative access complications and acute lower limb ischemia,all-cause mortality, AAA related mortality and incidence of serious adverse events (SAE) at 180 and 360 days. Secondary efficacy endpoints were the incidence of type Ⅰ or Ⅲ endoleak,stent displacement,and conversion to open surgery or re-intervention at 180 and 360 days. Results: One hundred and fifty-six patients were enrolled,including 137 males and 19 females. The age was (68.9±6.9) years (range:48.2 to 84.6 years).Maximum aneurysm diameter was (50.8±11.2) mm (range:25.0 to 85.0 mm),diameter of proximal landing zone was (21.2±2.5) mm (range:17.0 to 29.5 mm),and length of proximal landing zone was (31.4±13.0) mm (range:11.0 to 75.0 mm).The incidence of MAE was 1.3% (2/156) at 30 days,both were all-cause death cases. The success rate of AAA treatment was 88.5% (138/156) at 360 days. No perioperative access complication and acute lower limb ischemia occurred. All-cause mortality was 2.0% (3/154) at 180 days and 2.6% (4/153) at 360 days,and there was no AAA related death. The incidence of SAE was 23.0%(35/152) at 180 days and 30.5%(46/151) at 360 days, and no device-related SAE occurred. The incidence of type Ⅰor Ⅲ endoleak was 3.4% (5/147) at 180 days and 3.5% (5/144) at 360 days. Conclusion: The new stent graft system is easy to operate,and early-term safety and effectiveness results are expected.
目的： 探讨使用国产新型覆膜支架系统腔内修复腹主动脉瘤的安全性和有效性。 方法： 本研究为前瞻性、多中心、单组目标值法临床研究。纳入2018年9月至2019年9月中国21家中心收治的接受植入国产新型腹主动脉覆膜支架治疗的腹主动脉瘤患者的资料，分析患者出院前，术后30、180及360 d的治疗结果。主要安全性终点指标为术后30 d的主要不良事件（MAE）发生率，主要有效性终点指标为术后360 d腹主动脉瘤治疗成功率。次要安全性终点指标为围手术期入路并发症和急性下肢缺血发生率，术后180、360 d全因病死率，腹主动脉瘤相关病死率及严重不良事件（SAE）发生率。次要有效性终点指标为术后180、360 d Ⅰ型或Ⅲ型内漏发生率，支架移位发生率、中转开腹手术或二次介入干预发生率。 结果： 研究共纳入156例患者，男性137例，女性19例，年龄（68.9±6.9）岁（范围：48.2~84.6岁）。动脉瘤最大直径为（50.8±11.2）mm（范围：25.0~85.0 mm），近端锚定区直径为（21.2±2.5）mm（范围：17.0~29.5 mm），锚定区长度为（31.4±13.0）mm（范围：11.0~75.0 mm）。术后30 d的MAE发生率为1.3%（2/156），均为死亡病例；术后360 d腹主动脉瘤治疗成功率为88.5%（138/156）。围手术期未发生支架输送相关并发症及急性下肢缺血；术后180 d全因病死率为2.0%（3/154），360 d为2.6%（4/153），无腹主动脉瘤相关死亡病例。术后180 d SAE发生率为23.0%（35/152），360 d为30.5%（46/151），未发生器械相关SAE。术后180 d 的Ⅰ型或Ⅲ型内漏发生率为3.4%（5/147），360 d为3.5%（5/144）。 结论： 本研究中验证的国产新型覆膜支架系统操作简便，早期安全性和有效性结果符合预期。.