Journal
REGENERATIVE BIOMATERIALS
Volume 9, Issue -, Pages -Publisher
OXFORD UNIV PRESS
DOI: 10.1093/rb/rbac049
Keywords
aortic dissection; stent-graft; expanded polytetrafluoroethylene; delivery system for interventional treatment; clinical translation of biomaterials
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Funding
- National Science Foundation of China [52130302, 21961160721]
- National Key R&D Program of China [2016YFC1100300]
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This study reports a trilayer stent-graft and its corresponding delivery system for the treatment of aortic dissection. The stent-graft exhibits excellent cytocompatibility and hemocompatibility in vitro and has been demonstrated to be safe and effective through animal experiments and clinical cases.
The aortic dissection (AD) is a life-threatening disease. The transcatheter endovascular aortic repair (EVAR) affords a minimally invasive technique to save the lives of these critical patients, and an appropriate stent-graft gets to be the key medical device during an EVAR procedure. Herein, we report a trilayer stent-graft and corresponding delivery system used for the treatment of the AD disease. The stent-graft is made of nitinol stents with an asymmetric Z-wave design and two expanded polytetrafluoroethylene (ePTFE) membranes. Each of the inner and outer surfaces of the stent-graft was covered by an ePTFE membrane, and the two membranes were then sintered together. The biological studies of the sintered ePTFE membranes indicated that the stent-graft had excellent cytocompatibility and hemocompatibility in vitro. Both the stent-graft and the delivery system exhibited satisfactory mechanical properties and operability. The safety and efficacy of this stent-graft and the corresponding delivery system were demonstrated in vivo. In nine canine experiments, the blood vessels of the animals implanted with the stent-grafts were of good patency, and there were no thrombus and obvious stenosis by angiography after implantation for 6 months. Furthermore, all of the nine clinical cases experienced successful implantation using the stent-graft and its postrelease delivery system, and the 1-year follow-ups indicated the preliminary safety and efficacy of the trilayer stent-graft with an asymmetric Z-wave design for interventional treatment.
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