Safety and feasibility study of non-invasive robot-assisted high-intensity focused ultrasound therapy for the treatment of atherosclerotic plaques in the femoral artery: Protocol for a pilot study

Michelle V. Simons, Marijn H.A. Groen, Gert J. De Borst, Tim Leiner, Pieter A.F. Doevendans, Emad Ebbini, Fons J.B. Slieker, Rene Van Es, Constantijn E.V.B. Hazenberg

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

Abstract

INTRODUCTION: Peripheral arterial disease (PAD) is an atherosclerotic disease leading to stenosis and/or occlusion of the arterial circulation of the lower extremities. The currently available revascularisation methods have an acceptable initial success rate, but the long-term patency is limited, while surgical revascularisation is associated with a relatively high perioperative risk. This urges the need for development of less invasive and more effective treatment modalities. This protocol article describes a study investigating a new non-invasive technique that uses robot assisted high-intensity focused ultrasound (HIFU) to treat atherosclerosis in the femoral artery.

METHODS AND ANALYSIS: A pilot study is currently performed in 15 symptomatic patients with PAD with a significant stenosis in the common femoral and/or proximal superficial femoral artery. All patients will be treated with the dual-mode ultrasound array system to deliver imaging-guided HIFU to the atherosclerotic plaque. Safety and feasibility are the primary objectives assessed by the technical feasibility of this therapy and the 30-day major complication rate as primary endpoints. Secondary endpoints are angiographic and clinical success and quality of life.

ETHICS AND DISSEMINATION: Ethical approval for this study was obtained in 2019 from the Medical Ethics Committee of the University Medical Center Utrecht, the Netherlands. Data will be presented at national and international conferences and published in a peer-reviewed journal.

TRIAL REGISTRATION NUMBER: NL7564.

Original languageEnglish (US)
Article numbere058418
JournalBMJ open
Volume12
Issue number5
DOIs
StatePublished - May 2 2022

Bibliographical note

Publisher Copyright:
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Keywords

  • Ultrasound
  • Vascular medicine
  • Vascular surgery
  • Constriction, Pathologic
  • Plaque, Atherosclerotic/diagnostic imaging
  • Humans
  • Peripheral Arterial Disease/diagnostic imaging
  • Femoral Artery/diagnostic imaging
  • Robotics
  • Feasibility Studies
  • Pilot Projects
  • Atherosclerosis/therapy
  • Extracorporeal Shockwave Therapy
  • Lower Extremity
  • Quality of Life

PubMed: MeSH publication types

  • Journal Article
  • Research Support, Non-U.S. Gov't

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