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ID
Source
Brief title
Health condition
Buttock claudication after overstenting of internal iliac artery
Sponsors and support
Intervention
Outcome measures
Primary outcome
BOLD MRI signal parameters at day 1. Presence or absence of buttock claudication at day 1, after 3 and after 12 months
Secondary outcome
Safety of the procedure
Background summary
Endovascular aorta repair (EVAR) has become the treatment of first choice for
patients with an aneurysm of the abdominal aorta. In the Netherlands, approximately 3100 (75%) patients will be treated using the EVAR-procedure each year. Up to 20% of these patients have a concomitant aneurysm of the common iliac artery. For adequate prevention of the aneurysms, occlusion (by coiling or plug placement) of the ipsilateral internal iliac artery is required. Approximately, 30% of patients have long-term, persisting buttock claudication. No predictive tests exist to provide an adequate estimation of the risk of persisting buttock claudication after internal iliac artery occlusion. Our group developed (non-)invasive tests using blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI) techniques. Within this study, feasibility for predicting buttock claudication using the different tests will be evaluated.
Study objective
The blood oxygen level dependent MRI signal can be used to predict buttock claudication after coiling of the internal iliac artery
Study design
BOLD-parameters at day 1.
Questionnaires to score buttock claudication: Walking impairment questionnaire, vascular quality of life questionnaire, Questionnaire for objectifying buttock claudication answered at day 1, after 3 months and after 12 months
Intervention
Inducing hypo, and hyperaemia in the gluteus maximus muscle by temporally occluding the internal iliac artery or by gluteus maximus muscle activation. The changing oxygen levels during both tests will be monitored using the BOLD MRI sequence
Inclusion criteria
Patients scheduled for elective EVAR with internal iliac artery coiling
Iliac branched device placement not possible for technical reasons
of pre-existing buttock claudication
Exclusion criteria
Claustrophobia for MRI
<18 years old
No informed consent
Symptomatic- or ruptured aneurysm
Claustrophobia (regarding small MR bore)
Pacemaker
Non-MRI compatible implants
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL8810 |
CCMO | NL72133.091.19 |
OMON | NL-OMON49776 |