First-in-man use of DMUA/HIFU therapy for the treatment of atherosclerotic plaques in the femoral artery

1. Maximal patient age is 85 years
2. Patient is diagnosed with symptomatic peripheral arterial disease (ankle brachial index <0,9), with focal
localisation proximally in the femoral artery
3. Patient has a (non-stented, non-restenotic) target lesion with a 50-90% occlusion or symptoms with a total
lesion length of ≤ 40mm.
4. Presence of CTA-imaging of the target lesion in the patient’s medical file at baseline (<2 year old), from which
the max depth (<35mm) of the femoral arterial posterior wall from the skin surface is measured and the degree of
plaque calcification can be measured.
5. The target vessel and/or lesion must be visible on ultrasound-imaging of the DMUA/HIFU-system.

1. Patient is diagnosed with early onset peripheral arterial disease.
2. The maximum distance from the skin surface to the dorsal vessel wall exceeds 35 mm
3. The research team is unable to locate target vessel/lesion with ultrasound-imaging of the DMUA/HIFU-system
4. Volume of calcified areas in the plaque more than 30% of the culprit lesion, and/or distribution of calcification in
the culprit lesion which the research team considers not suitable for HIFU-treatment after preprocedural
assessment of existing CTA-images.
5. Plaque that in the opinion of the research team is unsuitable for HIFU-treatment after baseline screening of
patients. For example, unstable plaque (e.g. thin fibrous cap, or intraplaque haemorrhage).
6. Presence of any anatomical structures located near the focus of the HIFU beam, that in the opinion of the study
team would interfere with safe delivery of the therapy (e.g. nerves, bone, extensive scar tissue).
7. History of prior femoral artery stenting at the contemplated target location.
8. Recent (<6 months) cardiovascular event (myocardial infarction, unstable angina pectoris, TIA/CVA) or major
surgery.
9. Contraindication for antiplatelet therapy (e.g. high risk of bleeding, severe renal insufficiency)
10. Any serious medical condition or any other (medical, physical, anatomical) considerations, which in the opinion
of the study team may adversely affect the safety of the participant in the study
11. Individual has any contraindications for any of the study investigations (e.g. claustrophobia for MRI).
12. Individual has a known, unresolved history of substance abuse or alcohol dependency, lacks the ability to
comprehend or follow instructions or would be unlikely or unable to comply with the study protocol.
13. Individual is currently enrolled in another investigational or device trial.
14. Individual is pregnant, nursing or planning to be pregnant.