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Optimized Stents for the Femoropopliteal Artery

Award Number: R01HL125736
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 12/01/2014
PERIOD OF PERFORMANCE END DATE: 02/28/2025

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Optimized Stents for the Femoropopliteal Artery - PROJECT SUMMARY Angioplasty and stenting for Peripheral Arterial Disease (PAD) of the femoropopliteal artery (FPA) carries one of the highest rates of reconstruction failure because the FPA experiences low blood flow and large deformations during flexion of the limbs. Our results using perfused human cadaver models and PAD patients demonstrate that these deformations are significantly more severe than assumed previously, and that none of the existing PAD stents are able to adequately accommodate them, resulting in adverse stent-artery interactions that contribute to treatment failure. Informed by the mechanical and structural characteristics of human FPAs determined by studying >900 human arteries of different ages with different risk factors, and utilizing knowledge gained from studying 12 different commercial PAD stents, we propose to focus the current project on translating the results we obtained using human cadaver models to patients, and testing the hypothesis that a new optimized stent design capable of withstanding the severe biomechanical environment of the flexing limbs improves arterial healing. We will accomplish this through three Specific Aims. In Aim 1 we will validate cadaveric limb flexion-induced deformations using bent-limb patient CTAs at baseline and at 9 and 18 months after stenting. These data will allow us to translate results previously obtained using human cadavers to PAD patients, and to validate the ability of our computational models to predict location and severity of restenosis as a function of patient, lesion, and stent characteristics. In Aim 2 we will develop and manufacture optimized and generic stents for the FPA that would be able to accommodate limb flexion induced deformations while maintaining low intramural stresses and optimal hemodynamics. These stents will then be manufactured and evaluated in silico and in vitro in comparison with existing commercial devices. Finally, in Aim 3 we will compare optimal, generic, and commercial stents in a preclinical swine model of limb flexion, where performance of our optimized stent design will be compared to the generic design, and to one of the most commonly used commercial stents (Zilver) implanted in the popliteal artery. Validation of cadaveric FPA deformations in live PAD patients, and design of an optimized lower extremity stent may facilitate more durable reconstructions benefiting PAD patients with claudication and critical limb ischemia. Our extensive knowledge of FPA biomechanics and mechanobiology combined with deep understanding of commercial stent designs and computational models of limb flexion-induced deformations, will ensure successful completion of the new Aims, and will promote cost-effective in silico comparative effectiveness studies of current and future cardiovascular devices, helping advance the paradigm of patient-specific modeling and personalized medicine.


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: 2024 ( Subtotal = $525,999 )
2024	2024	UNIVERSITY OF NEBRASKA	6001 DODGE ST EAB 209	OMAHA	NE	68182	DOUGLAS	USA	Cardiovascular Diseases Research	001	10	6/20/2024	NON-COMPETING CONTINUATION	$42,939
2024	2024	UNIVERSITY OF NEBRASKA	6001 DODGE ST EAB 209	OMAHA	NE	68182	DOUGLAS	USA	Cardiovascular Diseases Research	000	10	3/11/2024	NON-COMPETING CONTINUATION	$483,060
														Subtotal = $525,999

Issue Date FY: 2023 ( Subtotal = $536,734 )
2023	2023	UNIVERSITY OF NEBRASKA	6001 DODGE ST EAB 209	OMAHA	NE	68182	DOUGLAS	USA	Cardiovascular Diseases Research	000	9	3/6/2023	NON-COMPETING CONTINUATION	$536,734
														Subtotal = $536,734

Issue Date FY: 2022 ( Subtotal = $536,734 )
2022	2022	UNIVERSITY OF NEBRASKA	6001 DODGE ST EAB 209	OMAHA	NE	68182	DOUGLAS	USA	Cardiovascular Diseases Research	000	8	2/10/2022	NON-COMPETING CONTINUATION	$483,057
2022	2022	UNIVERSITY OF NEBRASKA	6001 DODGE ST EAB 209	OMAHA	NE	68182	DOUGLAS	USA	Cardiovascular Diseases Research	001	8	5/24/2022	NON-COMPETING CONTINUATION	$53,677
														Subtotal = $536,734

Issue Date FY: 2021 ( Subtotal = $536,734 )
2021	2021	UNIVERSITY OF NEBRASKA	6001 DODGE ST EAB 209	OMAHA	NE	68182	DOUGLAS	USA	Cardiovascular Diseases Research	002	7	2/13/2021	NON-COMPETING CONTINUATION	$536,734
2021	2020	UNIVERSITY OF NEBRASKA	6001 DODGE ST EAB 209	OMAHA	NE	68182	DOUGLAS	USA	Cardiovascular Diseases Research	001	6	10/13/2020	COMPETING CONTINUATION	$292,765
2021	2019	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Cardiovascular Diseases Research	000	5	10/13/2020	NON-COMPETING CONTINUATION	-$292,765
														Subtotal = $536,734

Issue Date FY: 2020 ( Subtotal = $548,359 )
2020	2020	UNIVERSITY OF NEBRASKA	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Cardiovascular Diseases Research	002	6	3/10/2020	COMPETING CONTINUATION	$0
2020	2020	UNIVERSITY OF NEBRASKA	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Cardiovascular Diseases Research	001	6	2/22/2020	COMPETING CONTINUATION	$548,359
2020	2019	UNIVERSITY OF NEBRASKA	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Cardiovascular Diseases Research	000	5	2/21/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $548,359

Issue Date FY: 2019 ( Subtotal = $686,257 )
2019	2019	UNIVERSITY OF NEBRASKA	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Cardiovascular Diseases Research	001	5	12/11/2018	NON-COMPETING CONTINUATION	$686,257
2019	2019	UNIVERSITY OF NEBRASKA	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Cardiovascular Diseases Research	002	5	7/24/2019	NON-COMPETING CONTINUATION	$0
2019	2018	UNIVERSITY OF NEBRASKA	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Cardiovascular Diseases Research	000	4	11/27/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $686,257

Issue Date FY: 2018 ( Subtotal = $686,257 )
2018	2018	UNIVERSITY OF NEBRASKA	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Cardiovascular Diseases Research	000	4	12/7/2017	NON-COMPETING CONTINUATION	$672,531
2018	2018	UNIVERSITY OF NEBRASKA	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Cardiovascular Diseases Research	001	4	5/15/2018	NON-COMPETING CONTINUATION	$13,726
														Subtotal = $686,257

Issue Date FY: 2017 ( Subtotal = $686,257 )
2017	2017	UNIVERSITY OF NEBRASKA	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Cardiovascular Diseases Research	000	3	11/14/2016	NON-COMPETING CONTINUATION	$686,257
														Subtotal = $686,257

Issue Date FY: 2016 ( Subtotal = $747,890 )
2016	2016	UNIVERSITY OF NEBRASKA MEDICAL CENTER	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Cardiovascular Diseases Research	000	2	11/2/2015	NON-COMPETING CONTINUATION	$673,101
2016	2016	UNIVERSITY OF NEBRASKA MEDICAL CENTER	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Cardiovascular Diseases Research	001	2	2/3/2016	NON-COMPETING CONTINUATION	$74,789
														Subtotal = $747,890

Issue Date FY: 2015 ( Subtotal = $760,515 )
2015	2015	UNIVERSITY OF NEBRASKA MEDICAL CENTER	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Cardiovascular Diseases Research	000	1	11/17/2014	NEW	$760,515
														Subtotal = $760,515

Grand Total All Awards = $6,251,736

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Optimized Stents for the Femoropopliteal Artery

Award Number: R01HL125736

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 12/01/2014

PERIOD OF PERFORMANCE END DATE: 02/28/2025

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