atherosclerosis plaque
Conditions
Interventions
All patients will be treated with the dual-mode ultrasound array (DMUA) system
to deliver imaging-guided high-intensity focused ultrasound (HIFU) to the
atherosclerotic plaque.
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 80% 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the safety of DMUA / HIFU therapy for the treatment of symptomatic atherosclerotic plaques of the femoral artery, the thirty-day major complication rate will be used as primary endpoint. The 30-day procedure related major complication rate is a composite safety endpoint, based on previously validated safety endpoints for symptomatic peripheral arterial disease. It consists of the 30-day major adverse limb event (MALE) rate, which is defined as any complication that requires endovascular revascularization, open revascularization, or amputation in the target limb. Secondly, it consists of the 30-day mortality rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| See studyprotocol chapter 7.1.1., 7.1.2., 7.2. Technical To investigate the feasibility of the DMUA / HIFU therapy for the treatment of symptomatic atherosclerotic plaques of the femoral artery, technical parameters defined as technical success (protocol 7.1.2.) will be used. Magnetic resonance imaging (MRI) parameters To investigate changes in morphology of the symptomatic atherosclerotic plaque and the vascular lumen, the femoral artery will be imaged before, 1 day after and 30 days after treatment (protocol 7.2). Echo-duplex parameters To investigate vascular patency, changes in duplex imaging of the common femoral artery before and during follow-up will be measured (protocol 7.2) Clinical parameters To investigate changes in functional performance of the patient, the 6-minute walking test will be used to measure the walking distance before the procedure and 30 days after the procedure (protocol 7.2). To investigate changes in vascular patency, the ankle-brachial index will be measured before the procedure during follow-up (protocol 7.2). Secondary safety endpoint To investigate the 30-day and 90-day overall complication rate, consisting of both minor (protocol 7.1.2.) and major complications (protocol 7.1.1.) that might occur within 30 and 90 days of the procedure Quality of life parameters To investigate changes in the patient*s quality of life, the patient will be asked to fill in a Dutch *quality of life questionnaire*, specifically designed for patients with peripheral arterial disease, at baseline visit and during follow-up (appendix B) | — |
Countries
Netherlands
Outcome results
None listed