Razavi Mahmood, Lichtenberg Michael, Desai Kush, Dexter David, Soukas Peter, Shammas Nicolas, Lodha Ankur, Gagne Paul, Nordell Anna, Kolluri Raghu, Garcia Mark
Department of Interventional Radiology, St. Joseph Heart and Vascular Center, Orange, CA.
Department of Angiology, Vascular Center Arnsberg, Arnsberg.
J Vasc Surg Venous Lymphat Disord. 2025 Mar;13(2):101995. doi: 10.1016/j.jvsv.2024.101995. Epub 2024 Oct 29.
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 nonmalignant iliofemoral venous obstructive disease.
This was an international, prospective, multicenter, single-arm study that enrolled patients with symptomatic nonthrombotic (NT), post-thrombotic (PTS), or acute deep vein thrombotic (aDVT) iliofemoral venous outflow obstruction. The primary safety end point was freedom from major adverse events at 30 days after the index procedure. The primary efficacy end point was primary patency of stent-bearing segments at 12 months. Secondary and observational end points included symptom relief, primary-assisted patency, secondary patency, and device success. Patients remain in follow-up for 36 months.
A total of 162 patients were enrolled at 30 sites in the United States and Poland. The primary safety end point was achieved in 98.7% of patients against a predefined performance goal of 89.0% (P < .0001). The primary safety end point was achieved in 100%, 95.0%, and 100% of the NT, PTS, and aDVT cohorts, respectively. The primary efficacy end point was met in 90.2% compared with the performance goal of 77.3% (P = .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.
Through 12 months, the Duo Venous Stent System is safe and effective for the treatment of nonmalignant iliofemoral venous obstructive disease.
The VIVID (Venous stent for the Iliofemoral Vein Investigational clinical trial using the Duo Venous Stent System) investigational device exemption trial is the first study of a hybrid, venous stent specifically designed to address the anatomic challenges of the iliofemoral venous system. The Duo Venous Stent System consists of a self-expanding nitinol Duo Hybrid Stent used independently or in conjunction with the flexible extension Duo Extend Stent. This is the first report of primary outcomes from the VIVID Study, assessing the safety and efficacy of the Duo Venous Stent System to treat patients with nonmalignant, symptomatic iliofemoral venous outflow obstruction. The Duo Venous Stent System successfully met its 12-month safety and effectiveness performance goals.
髂股静脉段支架置入存在不同的解剖学和力学要求；双静脉支架系统旨在解决这些问题。VIVID（使用双静脉支架系统进行髂股静脉研究性临床试验的静脉支架）研究的目的是调查双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、前瞻性、多中心、单臂研究，纳入有症状的非血栓形成（NT）、血栓形成后（PTS）或急性深静脉血栓形成（aDVT）髂股静脉流出道阻塞的患者。主要安全终点是在索引手术后30天无重大不良事件。主要疗效终点是12个月时支架支撑段的原发性通畅。次要和观察终点包括症状缓解、原发性辅助通畅、继发性通畅和器械成功率。患者随访36个月。
在美国和波兰的30个地点共纳入了162例患者。98.7%的患者达到了主要安全终点，而预定义的性能目标为89.0%（P <.0001）。NT、PTS和aDVT队列分别有100%、95.０%和100%的患者达到主要安全终点。90.2%的患者达到了主要疗效终点，而性能目标为77.3%（P = .0002）。NT疾病患者中有95.2%、PTS患者中有79.4%、aDVT患者中有86.7%观察到原发性通畅。在12个月内未发生支架断裂、迁移或栓塞。患者报告的结果显示，从基线到6个月和12个月，静脉临床严重程度评分、维拉塔评分、EQ-5D-3L评分和VEINES-QoL/Sym评分均有改善。
在12个月的时间里，双静脉支架系统治疗非恶性髂股静脉阻塞性疾病是安全有效的。
VIVID（使用双静脉支架系统进行髂股静脉研究性临床试验的静脉支架）研究性器械豁免试验是第一项关于专门设计用于应对髂股静脉系统解剖挑战的混合静脉支架的研究。双静脉支架系统由可单独使用或与柔性延伸双延伸支架联合使用的自膨胀镍钛诺双混合支架组成。这是VIVID研究主要结果的首次报告，评估了双静脉支架系统治疗非恶性、有症状的髂股静脉流出道阻塞患者的安全性和有效性。双静脉支架系统成功达到了其12个月的安全和有效性性能目标。
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