Six-month safety and efficacy outcomes from the randomized-controlled arm of the WRAPSODY Arteriovenous Access Efficacy (WAVE) trial.

Percutaneous transluminal angioplasty (PTA) is the standard therapy for stenosis.

经皮腔内血管成形术（PTA）是治疗狭窄的标准疗法。

However, rates of restenosis and loss of access patency remain high.

然而，再狭窄和通路通畅性丧失的比率仍然很高。

Outcomes of a novel cell-impermeable endoprosthesis (CIE) have not been investigated in this setting.

这种新型细胞不可渗透的内支架（CIE）在这种情况下的结果尚未被研究。

Therefore, our study was designed to address this as a prospective, international, multicenter pivotal trial (NCT04540302) with 245 patients with stenosis in their venous outflow circuit randomized to treatment: 122 receiving CIE and 123 receiving PTA across 43 international centers.

因此，我们的研究设计为一项前瞻性、国际性、多中心的关键性试验（NCT04540302），共有245名静脉流出道狭窄患者随机接受治疗：122名接受CIE治疗，123名接受PTA治疗，试验在43个国际中心进行。

Primary endpoints included target lesion primary patency (TLPP) at six months (freedom from clinically driven target lesion revascularization or target lesion thrombosis) and freedom from safety events through 30 days post-index procedure that affected the access circuit and resulted in reintervention, hospitalization, or death.

主要终点包括六个月时的目标病变原发通畅率（TLPP）（无临床驱动的目标病变血运重建或目标病变血栓形成）以及从索引程序后30天内，影响通路并导致再次干预、住院或死亡的安全事件的自由度。

Access circuit primary patency (ACPP) was evaluated as a secondary efficacy endpoint.

导管通路原发通畅率（ACPP）被评估为次要疗效终点。

Six-month TLPP and ACPP were significantly higher for the CIE cohort versus PTA (TLPP: 89.6% vs. 62.3%; ACPP: 72.2% vs. 57.0%).

六个月时，经皮腔内血管成形术（PTA）组与腔内介入治疗（CIE）队列的经皮腔内血管成形术原发通畅率（TLPP）和ACPP显著更高（TLPP：89.6%对比62.3%；ACPP：72.2%对比57.0%）。

Thirty days post-index procedure, there was no statistically significant difference in the freedom from safety events for the CIE versus PTA (96.6 vs. 95.0%).

索引程序后30天，CIE与PTA在安全事件自由方面没有统计学上的显著差异（96.6%对比95.0%）。

No differences were observed in adverse events between either cohort.

在任一队列中，观察到不良事件之间没有差异。

Our study shows that among patients with stenosis in their AVF, the CIE was superior to PTA with respect to six-month TLPP and ACPP with no observed difference in 30-day primary safety events.

我们的研究表明，在AVF狭窄的患者中，与PTA相比，CIE在六个月的TLPP和ACPP方面表现更优，而在30天的主要安全事件方面没有观察到差异。