incidental intracranial aneurysms I67.1
Conditions
Interventions
Group 1: Treatment with Derivo Flow-Diverter
Sponsors
Universitätsklinikum Freiburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with intracranial aneurysms deemed treatable with the Derivo® flow-diverter 2. The target aneurysm cannot be treated with other endovascular techniques or there is a higher treatment risk with other endovascular or neurosurgical techniques. (= treatment within intended use) 3. The patients have read and understood the informations with respect to the study and have given their consent prior to aneurysm treatment with the Derivo® flow-diverter. 4. Modified Rankin score of 0 or 1
Exclusion criteria
Exclusion criteria: 1. Patients < 18 years of age 2. Patients with aneurysms related to arteriovenous malformations 3. Patients with known contraindications to antiplatelet therapy and/or anticoagulant therapy. 4. Pregnant or breast-feeding patients 5. Patients with confirmed subarachnoidal bleeding within the last two months 6. Patients likely to be unable to attend clinical and angiographic follow-up at 6 and 18 months 7. Patients with a contraindication according to the Instructions for use - The size of the aneurysm and/or the size of the aneurysma forming vessel is not within the indicated area. - An angiographically inappropriate vascular anatomy or vascular aberration for endovascular treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Rankin Score (mRS) at 18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Procedural result • Number of flow-diverters successfully deployed over aneurysm neck in relation to the number of attempted flow-diverter treatments as determined by the core-lab. • Wall apposition of the flow-diverter(s) per patient as determined by the core-lab: 1. correct wall apposition 2. gap between FD and vessel wall 25% of vessel diameter • Time needed for Derivo deployment. • Initial angiographic outcome: Core-lab evaluation of final controls with respect to the scale of Szikora • In those patients were additional coils are being used for aneurysm treatment the Montreal classification will apply for determining the treatment result in addition to the Szikora classification. • Procedural complication rate of aneurysm treatment 2) Post-procedural result • Number of new neurological deficits immediately after flow-diverter implantation • Initial clinical outcome: Comparison between initial Modified Ranking Scale (mRs) and mRs upon discharge. In those patient that had a procedural complication with subsequent stroke National Institutes of Health Stroke Scale (NIHSS) upon discharge. • Midterm (3-6 months) clinical outcome: mRs • Midterm (3-6 months) and longterm (12-18 months) angiographic outcome: Core-lab evaluation of mid-term angiographies with respect to the classification of Kamran Grading • In those patients were additional coils are being used for aneurysm treatment the Montreal classification will apply for determining the treatment result in addition to the Kamran grading system. • Quality of Life questionnaire SF-12 before treatment, after 3-6 and 12-18 months | — |
Countries
Germany, Poland
Contacts
Public ContactChristian Taschner
Universitätsklinikum Freiburg Klinik für Neuroradiologie
Outcome results
None listed