atherosclerosis peripheral arterial disease
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 18 years or older - Suspected presence of peripheral arterial disease based on duplex ultrasonography, magnetic resonance angiography or CT angiography requiring percutaneous intervention - willing and able to give informed consent
Exclusion criteria
Exclusion criteria: - Presence of metal implants incompatible with safe MR imaging as determined from the recent copy of the *MR safety manual* by Shellock et al. - claustrophobia - presence of metal fragments in the orbit or eye - severe renal impairment (GFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the diagnostic accuracy (sensitivity, specificity, NPV and PPV) for the detection and the severity (%) of peripheral vascular tree stenosis with subtractionless first-pass single contrast medium dose peripheral MR angiography using two-point mDixon fat suppression compared to IA-DSA in patients with peripheral arterial disease referred for percutaneous intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the diagnostic accuracy of subtractionless first-pass single mDixon MRA with conventional subtraction MRA compared to the reference standard DSA in patients with peripheral arterial disease referred for percutaneous intervention in participating centers performing subtraction MRA in their clinical routine workup. 2. Does mDixon MRA lead to similar treatment decisions as IA-DSA determined by an expert consensus panel consisting of experienced cardiovascular radiologists and vascular surgeons 3. To compare the diagnostic accuracy of mDixon MRA on a station by station level (i.e. at the aorto-iliac, upper leg and lower leg levels). | — |
Countries
Netherlands
Outcome results
None listed