# Optimized Stents for the Femoropopliteal Artery

> **NIH NIH R01** · UNIVERSITY OF NEBRASKA OMAHA · 2021 · $536,734

## Abstract

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.

## Key facts

- **NIH application ID:** 10113410
- **Project number:** 5R01HL125736-07
- **Recipient organization:** UNIVERSITY OF NEBRASKA OMAHA
- **Principal Investigator:** Alexey Kamenskiy
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $536,734
- **Award type:** 5
- **Project period:** 2014-12-01 → 2025-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10113410

## Citation

> US National Institutes of Health, RePORTER application 10113410, Optimized Stents for the Femoropopliteal Artery (5R01HL125736-07). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10113410. Licensed CC0.

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