To investigate the feasibility and safety of the DMUA-HIFU system for treatment of atherosclerotic plaques.
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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)
Background summary
Current treatment of lower extremity peripheral arterial disease consists of
risk factor modification, exercise therapy and pharmacological treatment
initially, but intervention is frequently needed when patients are
significantly disabled. Interventional treatment is invasive, either surgical
or percutaneous. This study investigates a new non-invasive technique that uses
high intensity focused ultrasound to treat atherosclerotic arterial disease
Study objective
To investigate the feasibility and safety of the DMUA-HIFU system for treatment
of atherosclerotic plaques.
Study design
Monocentre first-in-man non-randomized interventional pilot study (n=15).
Intervention
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.
Study burden and risks
Preclinical studies in healthy and diseased animals have demonstrated that the
use of the DMUA/HIFU therapy is safe. However, there is no previous experience
with this therapy in humans. With regard to the experience of the preclinical
studies, the risk of major adverse events like thrombotic events is considered
to be very low. The treatment is expected to be painless, but local skin
irritation may occur. If proven effective and safe, the DMUA/HIFU therapy can
represent a fast, simple and painless treatment that can be performed at the
outpatient clinic as an alternative to invasive surgical intervention.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
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 <= 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.
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL66436.041.18 |