Purpose

This prospective, observational first in human study evaluated the safety and effectiveness of WRAPSODY^TM Cell-impermeable Endoprosthesis (Merit Medical Systems, Inc.) in the treatment of arteriovenous fistula and arteriovenous graft access circuit stenosis.

Materials and Methods

Investigators conducted a prospective analysis of 46 patients with access circuit stenosis from three centres. Treatment sites included the peripheral outflow veins (e.g. cephalic arch, basilic vein swing point; 16 fistula and 10 graft patients); the graft-vein anastomosis (9 patients); and the central veins (up to, but not including the SVC; 11 patients). Primary outcome measures included 30-day freedom from access circuit-related safety events and 30-day target lesion primary patency. Secondary outcome measures included procedural success; device- and procedure-related adverse events; target lesion primary patency; access circuit primary patency; and secondary patency. In-person follow-up was scheduled at 1, 3, 6, and 12 months. An independent data monitoring/clinical event committee adjudicated all reinterventions and device/procedure-relatedness for adverse events.

Results

All initial procedures were successful. All but one patient was free from safety events through the first 30 days (97.8% (45/46)). This event was not device-related. Over the remainder of the study, one adverse event was adjudicated as possibly device-related. Six- and 12-month target lesion primary patency rates were 97.7% (42/43) and 84.6.% (33/39), respectively. Six- and 12-month access circuit primary patency rates were 84.4% (38/45) and 65.9% (29/44), respectively.

Conclusion

Results suggest that the study device is safe and effective for treatment of stenoses in the peripheral and central veins of arteriovenous access circuits.

Level of Evidence

Level 2b, cohort study.

中文翻译：

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Merit WRAPSODY™ 细胞不可渗透内置假体治疗血液透析患者通路狭窄的首个临床结果

目的

这项前瞻性、观察性的人体研究首次评估了 WRAPSODY ^TM细胞不可渗透内假体（Merit Medical Systems, Inc.）在治疗动静脉瘘和动静脉移植物通路狭窄方面的安全性和有效性。

材料和方法

研究人员对来自三个中心的 46 名通路狭窄患者进行了前瞻性分析。治疗部位包括外周流出静脉（如头弓、贵要静脉摆动点；16 例瘘管和 10 例移植患者）；移植静脉吻合术（9例）；和中央静脉（最多但不包括 SVC；11 名患者）。主要结果测量包括 30 天无通路相关安全事件和 30 天目标病变主要通畅率。次要结局指标包括手术成功率；设备和程序相关的不良事件；目标病灶原发性通畅；通路初级通畅；和二次通畅。面对面随访安排在第 1、3、6 和 12 个月。

结果

所有初始程序均成功。在前 30 天内，除一名患者外，所有患者均未发生安全事件（97.8% (45/46)）。此事件与设备无关。在研究的剩余时间里，一个不良事件被判定为可能与设备有关。6 个月和 12 个月的目标病变原发通畅率分别为 97.7% (42/43) 和 84.6.% (33/39)。6 个月和 12 个月的通路主要通畅率分别为 84.4% (38/45) 和 65.9% (29/44)。

结论

结果表明，该研究装置可安全有效地治疗动静脉通路的外周和中心静脉狭窄。

证据水平

2b 级，队列研究。