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Low-Profile 3D-Printed Radiopaque Bioresorbable Vascular Scaffolds

Award Number: R01HL141933
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 01/01/2019
PERIOD OF PERFORMANCE END DATE: 04/30/2028

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Low-Profile 3D-Printed Radiopaque Bioresorbable Vascular Scaffolds - PROJECT SUMMARY Atherosclerotic coronary artery disease (CAD) and peripheral artery disease (PAD) are responsible for significant morbidity, mortality, and high healthcare costs in the USA. This problem will continue to grow due to the diabetes epidemic as people with diabetes are at increased risk of developing atherosclerosis and less likely to have favorable treatment outcomes. Endovascular therapies such as placement of a metal stent that has been dilated by a balloon will open the blockage and restore blood flow. However, these therapies are plagued by relatively high restenosis rates, which have been attributed to the permanent presence of the stent. Polymeric bioresorbable vascular scaffolds (BVSs) have emerged as a potential solution to these problems by providing initial support to prevent recoil and slowly degrading to restore vasomotion and eliminate residual foreign materials that may contribute to restenosis. However, polymeric BVSs are difficult to fabricate (making them costly with limited design control) and are made from polymers such as poly(L-lactide) that are thrombogenic and cause oxidative tissue damage resulting in exacerbated inflammation. In addition, as in the case of the FDA-approved BVS Absorb GT1 from Abbott Vascular, the strut thickness has to be greater than 150 μm for the scaffold to have sufficient strength to prevent vessel recoil and to accommodate a polymer coating that contains an anti-restenotic drug to prevent stent re-occlusion. Clinical studies suggest that this strut thickness, which is 2 times larger than that of bare metal stents, leads to a high incidence of thrombosis in small-diameter arteries (<2.5 mm) and major adverse cardiac events, limiting the wide spread use of these devices due to their large profile. The Ameer and Sun research teams have been developing a liquid citrate- based biomaterial (CBB) that is compatible with a 3D printing technique referred to as micro continuous liquid interface production (μCLIP). CBBs, which are degradable, have been shown to be thromboresistant and antioxidant. These properties are desirable for vascular stents. The objective of this research proposal is to develop radiopaque, low-profile, drug-eluting, biocompatible and mechanically functional citrate-based BVS. We hypothesize that a low-profile citrate-based BVS fabricated via μCLIP will perform as well as the Abbott drug-eluting Xcience BVS in vivo. The specific aims are to: 1) Characterize, in vitro and in vivo in a standard swine model, low-profile, fluoroscopically visible BVSs fabricated using μCLIP, and 2) Assess the long-term safety and efficacy of fluoroscopically visible BVSs in atherosclerotic swine with metabolic syndrome. Specifically, we will investigate the patency, biocompatibility, and resorption of the BVS in coronary arteries of the Ossabaw miniature pig, which recapitulates human coronary atherosclerosis and metabolic syndrome.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Cardiovascular Diseases Research	001	5	5/22/2025	COMPETING CONTINUATION	$29,278
2025	2022	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Cardiovascular Diseases Research	000	4	5/22/2025	NON-COMPETING CONTINUATION	-$29,278
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $1,309,095 )
2024	2024	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Cardiovascular Diseases Research	002	5	7/31/2024	COMPETING CONTINUATION	$1,309,095
2024	2022	NORTHWESTERN UNIVERSITY	633 CLARK STREET	EVANSTON	IL	60208	COOK	USA	Cardiovascular Diseases Research	000	4	11/30/2023	NON-COMPETING CONTINUATION	$0
2024	2022	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Cardiovascular Diseases Research	001	4	7/25/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,309,095

Issue Date FY: 2022 ( Subtotal = $677,048 )
2022	2022	NORTHWESTERN UNIVERSITY	633 CLARK	EVANSTON	IL	60208	COOK	USA	Cardiovascular Diseases Research	001	4	6/8/2022	NON-COMPETING CONTINUATION	$67,705
2022	2022	NORTHWESTERN UNIVERSITY	633 CLARK	EVANSTON	IL	60208	COOK	USA	Cardiovascular Diseases Research	000	4	1/28/2022	NON-COMPETING CONTINUATION	$609,343
														Subtotal = $677,048

Issue Date FY: 2021 ( Subtotal = $765,704 )
2021	2021	NORTHWESTERN UNIVERSITY	633 CLARK	EVANSTON	IL	60208	COOK	USA	Cardiovascular Diseases Research	000	3	1/15/2021	NON-COMPETING CONTINUATION	$689,133
2021	2021	NORTHWESTERN UNIVERSITY	633 CLARK	EVANSTON	IL	60208	COOK	USA	Cardiovascular Diseases Research	001	3	5/24/2021	NON-COMPETING CONTINUATION	$76,571
														Subtotal = $765,704

Issue Date FY: 2020 ( Subtotal = $767,322 )
2020	2020	NORTHWESTERN UNIVERSITY	633 CLARK	EVANSTON	IL	60208	COOK	USA	Cardiovascular Diseases Research	000	2	1/31/2020	NON-COMPETING CONTINUATION	$767,322
														Subtotal = $767,322

Issue Date FY: 2019 ( Subtotal = $701,629 )
2019	2019	NORTHWESTERN UNIVERSITY	633 CLARK ST EVANSTON	EVANSTON	IL	60208	COOK	USA	Cardiovascular Diseases Research	000	1	12/21/2018	NEW	$701,629
														Subtotal = $701,629

Grand Total All Awards = $4,220,798

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Low-Profile 3D-Printed Radiopaque Bioresorbable Vascular Scaffolds

Award Number: R01HL141933

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 01/01/2019

PERIOD OF PERFORMANCE END DATE: 04/30/2028

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