NL-OMON24710RecruitingNot Applicable
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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Radboudumc
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
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.
Investigators
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