Minimal invasive follow up after flow diversion: comparison of subtraction computed tomography angiography, contrast enhanced magnetic resonance angiography and digital subtraction angiography as follow-up imaging modalities in flow diverter treatment for intracranial aneurysms

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the inclusion criteria as stated below:
-Aneurysm treated with a FD;
-=18 years;
-patients willing to provide written informed consent and comply with follow up requirements.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
-Known allergy (hypersensitivity or history of major immediate or delayed skin reaction to injection) or contraindication to the contrast agent Iomeron (manifest thyrotoxicosis, recent treatment with intravenous interleukin 2) or Dotarem;
-Use of nephrotoxic medicines (aminoglycosides, organoplatimun compounds, high doses of methotrexate, pentamidine, foscarnet, acyclovir, ganciclovir, valaciclovir, adefovir, cidofovir, tenofovir, vancomycin, amphotericin B, immunosuppressants such as cyclosporine or tacrolimus, isosfamide);
-Renal insufficiency (MDRD < 60 mL/min/1,73 m2);
-Patient who is currently participating in another clinical research study which might be influenced by the additional imaging investigations;
-Patients with a contraindication for MRA (e.g. metallic implants such as a pacemaker) or a metal clip in proximity to the studied aneurysm will only receive sCTA and DSA;
-Female of child-bearing potential who are known to be pregnant.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of false negative findings for aneurysm occlusion as measured by sCTA and ceMRA. This will be assessed according to modified Raymond-Roy (mRR) classification.

Secondary Outcome Measures

Name	Time	Method
-Positive predictive value, negative predictive value, sensitivity and specificity for complete aneurysm occlusion as measured by sCTA and ceMRA<br>-Degree of aneurysm occlusion according to mRR classification<br>-Parent artery patency (0-25% stenosis, >25-50% stenosis, >50-75% stenosis, >75-100% stenosis, parent vessel occlusion)<br>-Device deployment, wall apposition, neck coverage (scored as complete or incomplete)<br>-Complications related to the diagnostic methods<br>-Interreader agreement for all the imaging techniques