# A Novel Endovascular Approach to Remove Atherosclerotic Plaque Lesions In Situ

> **NIH NIH R01** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2020 · $717,432

## Abstract

SUMMARY
Cardiovascular disease secondary to atherosclerosis is the leading cause of death in the United States.
Current percutaneous vascular interventions that treat severe atherosclerosis require inflation of a balloon with
or without deployment of a rigid, non-compliant metal stent. Yet, this technique fails to remove the
atherosclerotic plaque burden and causes mechanical trauma to the arterial wall, resulting in significant
restenosis rates. FDA-approved plaque debulking technologies do exist and are used in the clinical arena.
However, to debulk the plaque, each of these therapies induces some form of mechanical or thermal injury to
the vessel wall, which ultimately stimulates the development of neointimal hyperplasia and results in significant
arterial restenosis. Therefore, the goal of this study is to develop a novel endovascular technology to
reduce atherosclerotic plaque burden without inducing thermal or mechanical trauma to the arterial
wall. Our paradigm-shifting technology is based on a safe method of digesting atherosclerotic plaque in situ
through the use of a double occlusion balloon catheter, sonication wire, and a highly customized solution
tailored to safely digest atherosclerotic plaque. Given that most atherosclerotic plaques are composed of
collagen, fibrin, lipids, proteoglycans, inflammatory cells, smooth muscle cells, and calcium, we hypothesize
that a digestion solution containing agents that target these plaque components will dissolve and
digest the plaque in situ within a clinically relevant time frame. Avoidance of the use of elastases in our
solution limits digestion of the plaque to the elastic lamina. With our multidisciplinary team of investigators, we
have already demonstrated the feasibility and initial safety of our approach through preliminary data. We have
demonstrated effective digestion of excised human carotid artery atherosclerotic plaques as well as the plaque
inside intact human superficial femoral arteries. We have evaluated our approach in a non-atherosclerotic
porcine model in vivo and showed that our therapy did not injure the arterial wall, was limited to the internal
elastic lamina, and did not result in dissections or aneurysm formation, suggesting that our therapy is safe.
Lastly, we evaluated our approach in an atherosclerotic porcine model and demonstrated initial efficacy at
reducing plaque without inducing thrombosis or aneurysmal degeneration. Given the feasibility and promise of
these preliminary data, we believe further scientific exploration and development of this novel technology is
warranted and will lead to an innovative clinical therapy for the treatment of atherosclerosis in humans. Thus,
the overall objective of this proposal is to robustly evaluate the safety, efficacy, durability, and
repeatability of this therapy in a preclinical porcine animal model of atherosclerosis. Successful
completion of these studies will directly lead to an FDA application for a first-in-human Phase...

## Key facts

- **NIH application ID:** 9841429
- **Project number:** 5R01HL129156-02
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** Melina Rae Kibbe
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $717,432
- **Award type:** 5
- **Project period:** 2019-01-01 → 2022-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9841429

## Citation

> US National Institutes of Health, RePORTER application 9841429, A Novel Endovascular Approach to Remove Atherosclerotic Plaque Lesions In Situ (5R01HL129156-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9841429. Licensed CC0.

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