Pivotal Evaluation of Novel Dedicated Venous Stent for Iliofemoral Venous Obstruction: A Prospective Cohort Study.

Autor:	Ma X; The Department of Vascular and Endovascular Surgery, The First Medical Center of Chinese PLA General Hospital, Beijing, China., Yang J; Zhongshan Hospital, Fudan University, Shanghai, China., Yin M; The Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China., Liu F; The Department of Vascular and Endovascular Surgery, The First Medical Center of Chinese PLA General Hospital, Beijing, China., Wu W; Beijing Tsinghua Changgung Hospital, Beijing, China., Li Y; Beijing Hospital, Beijing, China., Qin X; The First Affiliated Hospital of Guangxi Medical University, Guangxi, China., Zhang L; The First Hospital of Hebei Medical University, Shijiazhuang, China., Xiao Z; Hainan General Hospital, Hainan, China., Xu H; The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China., Zhu Y; The First People's Hospital of Changzhou, Changzhou, China., Wang L; Zhongshan Hospital, Fudan University (Xiamen Branch), Xiamen, China., Zhang J; Beijing Luhe Hospital, Capital Medical University, Beijing, China., Fan L; Zhongshan Hospital, Fudan University (Qingpu Branch), Shanghai, China., Dai X; Tianjin Medical University General Hospital, Tianjin, China., Yang M; Yantai Yuhuangding Hospital, Yantai, China., Chen B; The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, China., Hao B; Shanxi Bethune Hospital, Taiyuan, China., Lin S; The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China., Liao B; Physical Education Department, Hebei GEO university, Shijiazhuang, China., Fu W; Zhongshan Hospital, Fudan University, Shanghai, China., Guo W; The Department of Vascular and Endovascular Surgery, The First Medical Center of Chinese PLA General Hospital, Beijing, China.
Jazyk:	angličtina
Zdroj:	Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists [J Endovasc Ther] 2024 Apr 15, pp. 15266028241245325. Date of Electronic Publication: 2024 Apr 15.
DOI:	10.1177/15266028241245325
Abstrakt:	Purpose: The purpose was to evaluate the clinical outcomes of a dedicated venous stent with the tripartite composite segments for the treatment of iliofemoral venous obstruction (IVO) in a mixed cohort of nonthrombotic iliac vein lesion (NIVL) and post-thrombotic syndrome (PTS) over a period of 12 months. Methods: The Grency Trial is a prospective, multicenter, single-arm, open-label, pivotal study, which was conducted at 18 large tertiary hospitals in China from August 2019 to October 2020. A total of 133 hospitalized patients were screened and 110 patients with clinical, etiology, anatomical, and pathophysiology clinical class (CEAP) clinical grade C>3 and iliac vein stenosis >50% or occlusion, including 72 patients with NIVL and 38 patients with PTS, were implanted with Grency venous stents. Primary endpoint was stent patency at 12 months follow-up, and secondary outcomes were technical success; improvement in venous clinical severity score (VCSS) at 3, 6, and 12 month follow-up; and rates of clinical adverse events. Results: Among 110 patients who were implanted with Grency venous stents, 107 patients completed the 12 month follow-up. All 129 stents were successfully implanted in 110 limbs. Twelve-month primary patency rate was 94.39% [95% confidence interval [CI]=88.19%-97.91%] overall, and 100% [94.94%-100%] and 83.33% [67.19%-93.63%] in the NIVL and PTS subgroups, respectively. Venous clinical severity score after iliac vein stenting improved significantly up to 12 months follow-up. There were 3 early major adverse events (1 intracerebral hemorrhage and 2 stent thrombosis events related to anticoagulation therapy), and 7 late major adverse events (1 cardiovascular death, 1 intracranial hemorrhage with uncontrolled hypertension, and 5 in-stent restenosis cases without stent fractures or migration). Conclusions: The Grency venous stent system appeared excellent preliminary safe and effective for IVO treatment. Further large-scale studies with longer-term follow-up are needed to evaluate long-term patency and durability of stent. Clinical Impact: The design of venous stents for iliofemoral venous obstruction (IVO) must address engineering challenges distinct from those encountered in arterial stenting. The Grency venous stent, a nitinol self-expanding stent specifically tailored for IVO, features a composite structure designed to meet the stent requirements of various iliac vein segments. The Grency Trial is a prospective, multicenter, single-arm, open-label pivotal study aimed at evaluating the efficacy and safety of the Grency stent system. Following a 12-month follow-up period, the Grency venous stent system has demonstrated both safety and efficacy in treating iliofemoral venous outflow obstruction. Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu