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Development of a radiopaque, long-term drug eluting bioresorbable stent for the femoral-iliac artery.

ABSTRACT: Tubular tissues exist in various forms purported for blood supply, waste secretion, etc. to aid proper function and maintenance of the human body. Under pathological conditions, however, these tissues may undergo stenosis. A major surgical treatment for stenosis is to implant a medical device called a stent which aims to expand the narrowed tissue and maintain its patency. Most stents are currently made from metals; despite their high mechanical strength, however, interactions with the host tissue often results in restenosis and stent fracture. To solve these problems, a bioresorbable stent (BRS) is proposed as a next generation stent. In this study, a rotating rod combined 3D printing system was developed to fabricate various types of BRSs. In addition, we confirmed that a 1.5 year long-term release of paclitaxel is possible using polymeric materials. Moreover, a stent loaded with contrast powder was fabricated and was successfully viewed under fluoroscopy. The stent was then implanted in the iliac arteries of pigs and no adverse events were observed for up to 8 weeks.

SUBMITTER: Ha DH

PROVIDER: S-EPMC9073948 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Development of a radiopaque, long-term drug eluting bioresorbable stent for the femoral-iliac artery.

Ha Dong-Heon DH Kim Jae Yun JY Park Tae Sik TS Park Jong Ha JH Chae Suhun S Kim Byoung Soo BS Lee Han Cheol HC Cho Dong-Woo DW

RSC advances 20191028 59

Tubular tissues exist in various forms purported for blood supply, waste secretion, <i>etc.</i> to aid proper function and maintenance of the human body. Under pathological conditions, however, these tissues may undergo stenosis. A major surgical treatment for stenosis is to implant a medical device called a stent which aims to expand the narrowed tissue and maintain its patency. Most stents are currently made from metals; despite their high mechanical strength, however, interactions with the ho ...[more]

PMID: 35529974

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Project description:Background Early generation drug-eluting stents (DESs) showed a high grade of coronary endothelial dysfunction that was attributed to lack of stent reendothelialization. Endothelium-dependent vasomotor response of current DESs and bioresorbable scaffolds (BRSs) remains unknown. This study sought to assess the device-related endothelial function of current devices and to correlate neointima healing with endothelial function. Methods and Results A total of 206 patients from 4 randomized trials treated with the durable-polymer everolimus-eluting Xience (n=44), bioresorbable-polymer sirolimus-eluting Orsiro (n=35), polymer-free biolimus-eluting Biofreedom (n=24), bioactive endothelial-progenitor cell-capturing sirolimus-eluting Combo DES (n=25), polymer-based everolimus-eluting Absorb (n=44), and Mg-based sirolimus-eluting Magmaris BRS (n=34) underwent endothelium-dependent vasomotor tests and optical coherence tomography imaging, as per protocol, at follow-up. Crude vasomotor responses of distal segments to low-dose acetylcholine (10-6 mol/L) were different between groups: bioresorbablepolymer DEShad the worst (-8.4%±12.6%) and durable-polymer DES had the most physiologic (-0.4%±11.8%; P=0.014). High-dose acetylcholine (10-4 mol/L) showed similar responses between groups (ranging from -10.8%±11.6% to -18.1%±15.4%; P=0.229). Device healing was different between devices. Uncovered struts ranged from 6.3%±7.1% (bioresorbable-polymer DES) to 2.5%±4.5% (bioactive DES; P=0.056). In multivariate models, endothelium-dependent vasomotor response was associated with age, bioresorbable-polymer DES, and angiographic lumen loss, but not with strut coverage nor plaque type. Endothelial dysfunction (defined as ≥4% vasoconstriction) was observed in 46.6% of patients with low-dose and 68.9% with high-dose acetylcholine, without differences between groups. Conclusions At follow-up, endothelial dysfunction was frequently observed in distal segments treated with current stents without remarkable differences between devices. Although neointima healing was different between devices, poor healing was not associated with endothelial dysfunction.

Dataset Information

Development of a radiopaque, long-term drug eluting bioresorbable stent for the femoral-iliac artery.

Publications

Development of a radiopaque, long-term drug eluting bioresorbable stent for the femoral-iliac artery.

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