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| Name | Class |
|---|---|
| Brightfish | UNKNOWN |
| Nano4Imaging GmbH | INDUSTRY |
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An abdominal aortic aneurysm (AAA) is a pathological dilatation of the aorta in the belly which can rupture leading to bleeding within the belly. To prevent rupture elective surgery can be performed. Endovascular repair (EVAR) is a surgical intervention whereby a stent is inserted into the AAA to prevent it from further growth and rupture.
Standard AAA management has several drawbacks. To start: maximum AAA diameter is used to determine upon timing of elective repair but is imprecise in predicting the risk of rupture resulting in an unmet clinical need. Secondly, EVAR outcome and complication occurrence remain unpredictable due to poor prediction ability of computed tomography (CT) and ultrasound (US) utilised in the follow-up protocol. Lastly, patients and physicians are being repeatedly exposed to cumulative radiation toxicity. All these drawbacks could be solved by trading the standard imaging modalities by magnetic resonance imaging (MRI). Within the MARVY, advanced MRI techniques are used to find out if standard imaging techniques could be replaced by MRI in three phases of the AAA management (surveillance, surgery planning and post-operative follow-up). The two most important MRI techniques that will be used are 4D flow MRI and dynamic contrast enhanced (DCE) MRI which give respectively information about the blood flow within the AAA and perfusion of the aortic wall.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surveillance | 20 AAA patients will undergo two MRI scans with a half year interval to assess a possible correlation between MRI derived biomarkers and the clinical standard to assess aneurysm progression (maximum AAA diameter). |
| |
| EVAR planning | 10 patients will undergo magnetic resonance angiography next to the standard of CT angiography (CTA). It is investigated whether EVAR planning is feasible based on MRA and if or how measurements between MRA and CTA differ. |
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| EVAR follow-up | 30 AAA patients who underwent EVAR will be included in three groups: 10 patients with ten complication free years after EVAR or sac regression, 10 patients with endoleak type I and 10 patients with endoleak type II. It is investigated whether MRI can provide extra information for the detection of endoleaks after EVAR. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic resonance imaging (with PROUD software) | Device | Philips Ingenia 3.0T MR system with in-house developed PROUD software |
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| Measure | Description | Time Frame |
|---|---|---|
| Surveillance: correlation between growth rate and MRI derived parameters | The main study parameter for phase B1 (surveillance) is the correlation between growth rate of the AAA (determinant for the standard of care) and measured MRI parameters acquired with 4D flow MRI and DCE-MRI. | 1 year |
| EVAR planning: correlation between morphological parameters measured based on MRA and CTA | The main study parameter for phase B2 (EVAR planning) is the difference between anatomical measurements (lengths and diameters) based on both CTA and MRA. Several quantitative anatomical measurements will be utilised to assess the feasibility of MRA for planning of EVARs. | half year |
| EVAR follow up: difference in MRI parameters between patients with endoleaks and without | The main study parameter for phase B3 (EVAR follow-up) is the difference in MRI parameters measured post-operatively in patients with and without EVAR related complications. | 1 year |
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Inclusion Criteria:
Inclusion Criteria for surveillance part:
Inclusion Criteria for planning part:
Inclusion Criteria for follow-up part:
Exclusion Criteria:
Exclusion Criteria for surveillance part:
Exclusion Criteria for planning part:
Exclusion Criteria for follow-up part:
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Patients with an AAA from the Amsterdam UMC
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC | Amsterdam | North Holland | 1105 AZ | Netherlands |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D000098543 | Dynamic Contrast Enhanced Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D001018 |
| Aortic Diseases |