In-vivo validiation of a non-invasive, magnetic resonance-based patient-specific pressure model to determine the severity of common and external iliac artery obstructions, and the need for revascularization.
Completed
- Conditions
- Peripheral Arterial Disease (PAD)Perifeer arterieel vaatlijden (PAV)
- Registration Number
- NL-OMON22159
- Lead Sponsor
- St. Antonius Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
(1) Age over 18;
(2) Symptomatic, chronic atheroslerotic lesions of the common iliac artery or external iliac artery;
Exclusion Criteria
(1) Previous endovascular or surgical treatment of the target iliac arteries;
(2) Inability to undergo all measurements (e.g. usual MRI contra-indications);
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Validation of the personalized pressure model with intra-arterial pressure and flow measurements (model validation), and intravascular ultrasound (model input validation) that serves as the gold standard.
- Secondary Outcome Measures
Name Time Method Validation of the by the model predicted increase of blood pressure after successful intervention of the stenosis<br /><br /><br><br>Comparing the diameter estimated by conventional pre-procedural measurements techniques {i.e. visual inspection (”eye-balling”), Contrast Enhanced Magnetic Resonance Angiography (CE-MRA), High Spatial Resolution Magnetic Resonance Imaging (HR-MRI), standard angiography and angiography images analyzed by 3 dimensional Quantitative Vascular Analysis (QVA 3D) software (Pie Medical Imaging, Maastricht, The Netherlands) } with the gold standard (IVUS).