Preclinical Development and Testing of Innovative Bioresorbable Stents to Treat Patients with Severe Peripheral Arterial Disease

用于治疗严重外周动脉疾病患者的创新生物可吸收支架的临床前开发和测试

• 批准号: 104808
• 金额: $ 107.74万
• 依托单位: ARTERIUS LIMITED
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2019
• 资助国家: 英国
• 起止时间: 2019 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=104808
• 关键词: Preclinical; Development; Testing; Innovative; Bioresorbable

Peripheral vascular diseases (PVD) are caused by the formation of atherosclerotic plaques/blockages in arteries, which reduce blood supply to brain, heart, kidneys, liver/gut and limbs causing strokes, heart attacks, kidney failure and limb amputations. This condition is also known as peripheral artery occlusive disease or peripheral artery disease (PAD).The risks of PAD to patients has been reduced with the recent advent of thin-strut permanently implanted metallic balloon-expandable stents delivered percutaneously oevr a wire through a needle in the diseased/blocked peripheral artery. However, the presence of a permanent endovascular device in the artery is associated with a series of problems that can lead to re-narrowing/re-blockage (restenosis) of the arteries and stent clotting (thrombosis). Significant advances in the technology of biodegradable materials have made it possible to make vascular stents that are fully dissolvable over 18-24 months, also called bioresorbable stents (BRS). BRSs are able to mechanically keep opened/support the blockage of the diseased artery wall as well as elute a drug for a predetermined time period after which they are absorbed into the vascular wall. BRS are appealing to NHS clinicians, with potential to become the percutaneous treatment of choice for millions of PAD patients worldwide. Key developmental needs are: biodegradable materials, device/stent profile, wall thickness, thrombogenicity, degradation rate, biomechanical performance, and advanced in-vivo testing by clinical NHS experts, all key aspects that require an advanced multidisciplinary team of experts to ultimately deliver a new generation of BRSs that are safe, at much lower risk of late mechanical fracture and restenosis/thrombosis with a view to improve patient life expectancy and reduce markedly NHS costs.To this end, Arterius Limited, as the only UK company developing the next generation biodegradable coronary stents, has paired up with the Translational Biomedical Research Centre at the University of Bristol, as the only UK institutional preclinical research facility developing new drugs and biomedical devices at NHS, Home Office and GLPMA standards, to develop, test, and translate to bed side the new BRSs for vascular clinical applications. Together Arterius and TBRC Bristol create a unique UK based partnership able to take on this challenge to expand Arterius's product portfolio and achieve a global clinical reach beyond the already established coronary disease for patient, societal and economical benefits. In turn, this partnership will help TBRC to enhace its national/international projection as the only institutional advanced preclinical research centre in the UK/EU partnering with Industry.

外周血管疾病(PVD)是由动脉中形成的动脉粥样硬化斑块/堵塞引起的，这会减少大脑、心脏、肾脏、肝脏/肠道和四肢的血液供应，导致中风、心脏病发作、肾功能衰竭和肢体截肢。这种情况也被称为外周动脉闭塞症或外周动脉病(PAD)。随着最近薄型支架的出现，患者患PAD的风险降低了，金属球囊可扩张支架经皮通过针在病变/阻塞的外周动脉中传递。然而，动脉内永久性血管内装置的存在与一系列问题有关，这些问题可能导致动脉再次狭窄/再次阻塞(再狭窄)和支架凝结(血栓形成)。生物可降解材料技术的重大进步使得制造完全可溶于18-24个月的血管支架成为可能，也被称为生物可吸收支架(BRS)。BRs能够机械地保持开放/支持病变动脉壁的阻塞，并在预定的时间段内洗脱药物，之后它们被吸收到血管壁中。BRS对NHS临床医生很有吸引力，有可能成为全球数百万PAD患者的经皮治疗选择。关键的开发需求是：可生物降解材料、设备/支架型材、壁厚、血栓形成性、降解率、生物力学性能以及临床NHS专家的先进体内测试，所有这些关键方面都需要先进的多学科专家团队最终提供安全、晚期机械骨折和再狭窄/血栓风险低得多的新一代BRSS，以期延长患者预期寿命并显著降低NHS成本。为此，Arterius Limited作为唯一一家开发下一代可生物降解冠状动脉支架的英国公司，已与布里斯托尔大学翻译生物医学研究中心合作，作为英国唯一一家以NHS、Home Office和GLPMA标准开发新药和生物医学设备的机构临床前研究机构，开发、测试用于血管临床应用的新BRSS并将其转化为床边。Arterius和TBRC Bristol共同创建了一个独特的英国合作伙伴关系，能够应对这一挑战，扩大Arterius的产品组合，实现超越已经确立的冠心病的全球临床覆盖范围，从而为患者、社会和经济带来好处。反过来，这一合作关系将有助于TBRC加强其作为英国/欧盟与行业合作的唯一机构高级临床前研究中心的国家/国际预测。