# Treatment of tracheal stenosis by drug eluting, bioabsorbable stent

> **NIH VA I21** · LOUIS STOKES CLEVELAND VA MEDICAL CENTER · 2020 · —

## Abstract

Long-term intubation, tracheostomy, neck or inhalational trauma are common causes for subglottic and
tracheal stenosis. Current surgical techniques may not correct the condition in all cases, resulting in
restenosis and sometimes requiring a permanent tracheostomy. Tracheal stents can be used to address
stenosis, but they have a number of potential shortcomings such as such as risk of acute airway
obstruction, migration and poor biocompatibility. We have developed a novel drug-eluting stent concept
to effectively eliminate such shortcomings. We hypothesize that a mometasone-eluting highly
biocompatible multiphasic and spatially graded polycaprolactone-collagen (PCL-Col) stent that can treat
tracheal stenosis effectively. Collagen phase at the lumen of the stent will facilitate full mucosalization
whereas the macroporous PCL phase will biodegrade and release a steroid into the tracheal tissue to
prevent re-stenosis. In Aim 1, the design of the self-deploying tracheal stent will be optimized. Geometric
and compositional parameters of stent design will be varied to attain a stent, which expands and securely
stays within the trachea after deployment to provide adequate tracheal wall support. Biomechanical tests
will measure the strength of anchorage to avoid migration following stent expansion. Aim 2 will focus on
optimizing the anti-inflammatory and epithelialization capacity of the stent: mometasone content will be
systematically varied to study their anti-inflammatory effects using macrophage and airway epithelial cell
cultures. High performance liquid chromatography will be used to quantify the release profile of
mometasone over time. Aim 3 will focus on in vivo testing of the bioabsorbable, drug eluting stent: The
effectiveness of stents will be tested in a rabbit animal model in which stenosis will be induced chemically.
The following treatment groups will be included: (1) stenosis with no stent, (2) stenosis treated with a
commercially available silicone stent, (3) stenosis treated with a PCL-collagen stent, (4) stenosis treated
with a PCL-collagen-mometasone eluting stent. Stents will remain for 24 weeks in situ and longitudinally
monitored for inflammatory changes, epithelialization, healing tendency, stent migration, and airway
obstruction. At the completion of this project we will have obtained valuable pre-clinical data regarding
optimum stent biomechanics and composition, which will prepare us for further long-term experiments in
larger animals.

## Key facts

- **NIH application ID:** 9821158
- **Project number:** 5I21RX002901-02
- **Recipient organization:** LOUIS STOKES CLEVELAND VA MEDICAL CENTER
- **Principal Investigator:** Mark Weidenbecher
- **Activity code:** I21 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2020
- **Award amount:** —
- **Award type:** 5
- **Project period:** 2018-12-01 → 2021-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9821158

## Citation

> US National Institutes of Health, RePORTER application 9821158, Treatment of tracheal stenosis by drug eluting, bioabsorbable stent (5I21RX002901-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9821158. Licensed CC0.

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