Preclinical testing of a 3D printed external scaffold device to prevent vein graft failure after coronary bypass graft surgery

3D 打印外部支架装置预防冠状动脉搭桥手术后静脉移植失败的临床前测试

基本信息

  • 批准号:
    10385132
  • 负责人:
  • 金额:
    $ 34.51万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2022
  • 资助国家:
    美国
  • 起止时间:
    2022-09-15 至 2024-09-14
  • 项目状态:
    已结题

项目摘要

Saphenous vein graft (SVG) failure following coronary artery bypass grafting (CABG) is a critical clinical problem, with recent studies revealing that as many as 25% of vein grafts develop stenosis within 12-18 months after surgery, and up to 50% of grafts occlude within 5-10 years. CABG surgery is the gold standard treatment for patients with severe multi-vessel disease, with over 370,000 procedures performed annually in the U.S. and SVGs are used in 95% of cases. Identification of strategies and devices to prevent SVG failure represents a pressing unmet clinical need. BioGraft will address this unmet need by developing an external biodegradable scaffold device to prevent SVG failure. It is well established that mechanical loading contributes to the cellular and structural changes leading to SVG failure. In current clinical practice, when the SVG is harvested and implanted into the coronary circulation, it is subjected to an abrupt change in mechanical loading (20X change in pressure, 4X change in flow-induced shear), triggering SVG wall remodeling and, often, maladaptation and failure. Our foundational R01-funded research, which laid the scientific foundation for the founding of BioGraft, showed that gradual increases in loading could mitigate or even eliminate graft failure. We demonstrated this concept in vivo, showing more favorable graft adaptation with a first-generation design in an ovine model. Here, to achieve a design that can be manufactured at scale, we propose a next-generation 3D printed biodegradable scaffold, which we will refine and test in this proposal. To achieve our goals, we propose three specific aims. In Aim 1, we will screen 3D-printed design candidates with ex vivo testing and degradation studies. This will allow us to efficiently and inexpensively select designs matching desired targets. In Aim 2, we will perform pre-clinical testing of the scaffold device in an established ovine carotid-jugular interpositional vein graft model of CABG surgery. This will establish preliminary safety and efficacy. In Aim 3, we will characterize device performance using mechanical testing and histopathology. These data will enable follow up fundraising, development of a commercialization plan and initiation of FDA discussions. BioGraft’s founding team leverages a long-standing engineering and clinical collaboration and recent partnerships with renowned investigators at Stanford and Duke who hold IP for unique bioabsorbable materials and bring expertise in rapid 3D printing manufacturing methods. We see a potential annual $1.6B total addressable market for the proposed device.
冠状动脉旁路移植术(CABG)后隐静脉移植失败是一个重要的临床问题。

项目成果

期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)

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Alison L Marsden其他文献

Alison L Marsden的其他文献

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{{ truncateString('Alison L Marsden', 18)}}的其他基金

Computational Medicine in the Heart, Integrated Training Program
心脏计算医学综合培训计划
  • 批准号:
    10556918
  • 财政年份:
    2023
  • 资助金额:
    $ 34.51万
  • 项目类别:
SCH: INT: A Virtual Surgery Simulator to Accelerate Medical Training in Cardiovascular Disease
SCH:INT:加速心血管疾病医疗培训的虚拟手术模拟器
  • 批准号:
    10412769
  • 财政年份:
    2019
  • 资助金额:
    $ 34.51万
  • 项目类别:
SCH: INT: A Virtual Surgery Simulator to Accelerate Medical Training in Cardiovascular Disease
SCH:INT:加速心血管疾病医疗培训的虚拟手术模拟器
  • 批准号:
    10487534
  • 财政年份:
    2019
  • 资助金额:
    $ 34.51万
  • 项目类别:
SCH: INT: A Virtual Surgery Simulator to Accelerate Medical Training in Cardiovascular Disease
SCH:INT:加速心血管疾病医疗培训的虚拟手术模拟器
  • 批准号:
    10259714
  • 财政年份:
    2019
  • 资助金额:
    $ 34.51万
  • 项目类别:
Automated data curation to ensure model credibility in the Vascular Model Repository
自动数据管理以确保血管模型存储库中模型的可信度
  • 批准号:
    10175029
  • 财政年份:
    2019
  • 资助金额:
    $ 34.51万
  • 项目类别:
SCH: INT: A Virtual Surgery Simulator to Accelerate Medical Training in Cardiovascular Disease
SCH:INT:加速心血管疾病医疗培训的虚拟手术模拟器
  • 批准号:
    10020975
  • 财政年份:
    2019
  • 资助金额:
    $ 34.51万
  • 项目类别:
Automated data curation to ensure model credibility in the Vascular Model Repository
自动数据管理以确保血管模型存储库中模型的可信度
  • 批准号:
    10016840
  • 财政年份:
    2019
  • 资助金额:
    $ 34.51万
  • 项目类别:
Enabling reliable cardiovascular simulations via uncertainty quantification
通过不确定性量化实现可靠的心血管模拟
  • 批准号:
    9030537
  • 财政年份:
    2016
  • 资助金额:
    $ 34.51万
  • 项目类别:
Enabling reliable cardiovascular simulations via uncertainty quantification
通过不确定性量化实现可靠的心血管模拟
  • 批准号:
    9348646
  • 财政年份:
    2016
  • 资助金额:
    $ 34.51万
  • 项目类别:
Enabling reliable cardiovascular simulations via uncertainty quantification
通过不确定性量化实现可靠的心血管模拟
  • 批准号:
    9751081
  • 财政年份:
    2016
  • 资助金额:
    $ 34.51万
  • 项目类别:

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