The VIVID Trial 12-month outcomes of the Venous stent for the Iliofemoral Vein using the Duo Venous Stent System.

IF 2.8 2区医学 Q2 PERIPHERAL VASCULAR DISEASE Journal of vascular surgery. Venous and lymphatic disorders Pub Date : 2024-10-28 DOI:10.1016/j.jvsv.2024.101995

Mahmood Razavi, Michael Lichtenberg, Kush Desai, David Dexter, Peter Soukas, Nicolas Shammas, Ankur Lodha, Paul Gagne, Anna Nordell, Raghu Kolluri, Mark Garcia

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Abstract

Objective: There are varying anatomical and mechanical demands of stent placement in the iliofemoral venous segment; the Duo Venous Stent System is designed to address these issues. The purpose of the VIVID (Venous stent for the Iliofemoral Vein Investigational clinical trial using the Duo Venous Stent System) study was to investigate the safety and efficacy of the Duo Venous Stent System for the treatment of patients with non-malignant iliofemoral venous obstructive disease.

Methods: This was an international, prospective, multi-center, single-arm study that enrolled patients with symptomatic non-thrombotic (NT), post-thrombotic (PTS), or acute deep vein thrombotic (aDVT) iliofemoral venous outflow obstruction. The primary safety endpoint was freedom from major adverse events at 30 days post-index procedure. The primary efficacy endpoint was primary patency of stent-bearing segments at 12 months. Secondary and observational endpoints included symptom relief, primary assisted patency, secondary patency, and device success. Patients remain in follow-up for 36 months.

Results: A total of 162 patients were enrolled at 30 sites in the United States and Poland. The primary safety endpoint was achieved in 98.7% of patients against a predefined performance goal of 89.0% (P<0.0001). The primary safety endpoint was achieved in 100%, 95.0%, and 100% of the NT, PTS, and aDVT cohorts, respectively. The primary efficacy endpoint was met in 90.2% compared with the performance goal of 77.3% (P=0.0002). Primary patency was observed in 95.2% of patients with NT disease, 79.4% of those with PTS, and 86.7% of those with aDVT. No stent fracture, migration, or embolization occurred through 12 months. Patient reported outcomes showed improvements in Venous Clinical Severity Score, Villalta, EQ-5D-3L, and VEINES-QoL/Sym scores from baseline through 6 and 12 months.

Conclusions: Through 12 months, the Duo Venous Stent System is safe and effective for the treatment of non-malignant iliofemoral venous obstructive disease.

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VIVID 试验：使用 Duo 静脉支架系统对髂股静脉进行静脉支架治疗的 12 个月结果。

目的：在髂股静脉段放置支架有不同的解剖和机械要求；Duo 静脉支架系统就是为解决这些问题而设计的。VIVID（使用 Duo 静脉支架系统的髂股静脉静脉支架临床试验）研究旨在调查 Duo 静脉支架系统治疗非恶性髂股静脉阻塞性疾病患者的安全性和有效性：这是一项国际性、前瞻性、多中心、单臂研究，研究对象为有症状的非血栓性（NT）、血栓后（PTS）或急性深静脉血栓性（aDVT）髂股静脉流出道阻塞患者。主要安全性终点是指数手术后 30 天内无重大不良事件发生。主要疗效终点是12个月时支架承载区段的主要通畅性。次要和观察终点包括症状缓解、主要辅助通畅、次要通畅和装置成功。患者将继续随访 36 个月：美国和波兰的 30 个研究机构共招募了 162 名患者。98.7%的患者达到了主要安全终点，而预定的达标率为89.0%（PC结论：在12个月的随访中，Duo Venus的安全性和有效性均达到了预期目标：经过12个月的治疗，Duo静脉支架系统对治疗非恶性髂股静脉阻塞性疾病是安全有效的。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of vascular surgery. Venous and lymphatic disorders SURGERYPERIPHERAL VASCULAR DISEASE&n-PERIPHERAL VASCULAR DISEASE

CiteScore

6.30

自引率

18.80%

发文量

328

审稿时长

71 days

期刊介绍： Journal of Vascular Surgery: Venous and Lymphatic Disorders is one of a series of specialist journals launched by the Journal of Vascular Surgery. It aims to be the premier international Journal of medical, endovascular and surgical management of venous and lymphatic disorders. It publishes high quality clinical, research, case reports, techniques, and practice manuscripts related to all aspects of venous and lymphatic disorders, including malformations and wound care, with an emphasis on the practicing clinician. The journal seeks to provide novel and timely information to vascular surgeons, interventionalists, phlebologists, wound care specialists, and allied health professionals who treat patients presenting with vascular and lymphatic disorders. As the official publication of The Society for Vascular Surgery and the American Venous Forum, the Journal will publish, after peer review, selected papers presented at the annual meeting of these organizations and affiliated vascular societies, as well as original articles from members and non-members.