Follow-up of intracranial aneurysms treated with the Surpass flow diverter: comparison of subtraction CTA and DSA. Part I: a prospective case cohort study

Completed

• Conditions: vascular ectasia; vessel wall protrusion; 10007963; 10002363

• Registration Number: NL-OMON42510
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

adults (age: 18 to 80) with an unruptured intracranial aneurysm treated with Surpass.

Exclusion Criteria

subarachnoid hemorrhage, earlier coiled aneurysm, allergy (hypersensitivity to iobitridol, history of major immediate or delayed skin reaction to Iobitridol injection) or contraindication to contrast agent (manifest thyrotoxicosis, recent treatment with intravenous interleukin 2), use of nephrotoxic medicines (aminoglycosides, organoplatinum compounds, high doses of methotrexate, pentamidine, foscarnet, aciclovir, ganciclovir, valaciclovir, adefovir, cidofovir, tenofovir, vancomycin, amphotericin B, immunosuppressants such as ciclosporine or tacrolimus, ifosfamide), contraindication to CT scan, renal insufficiency, pregnancy, and age <18 years.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main parameter is the difference in the degree of aneurysm occlusion. This<br /><br>will be measured by:<br /><br>- Calculation of the aneurysm volume with residual contrast filling.<br /><br>- The Raymond classification.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters:<br /><br>The patency of the parent vessel will be measured on a 4-point scale.<br /><br>Complications will be registered.</p><br>