The value of flow measurements in brain Aneurysms
- Conditions
- Health Condition 1: G938- Other specified disorders of brain
- Registration Number
- CTRI/2019/04/018743
- Lead Sponsor
- Philips
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Subject with unruptured, 5rnm saccular aneurysm(s) located in the anterior intracranial
circulation and suitable for an endovascular treatment with a Flow Diverter Stent
2. Subject is 18 years of age or older, or of legal age to give informed consent per state or national law
3. Subject is available for clinical follow-ups
1. Non-saccular brain aneurysm(s) (i.e., dissecting, fusiform, atherosclerotic, mycotic, bifurcational)
2. Prior aneurysm treatment with either endovascular (stenting, coiling) or surgical (clipping) techniques
3. Endovascular treatment assisted with coils or intracranial stents
4. Significant or severe allergy to intra-arterial contrast medium uncontrolled by pre-procedure medications
5. Severe kidney disease (e-GFR < 60)
6. Subjects not willing (or able) to attend post FDS insertion standard-of-care follow up clinic visits requiring DSA, head MRI or CTA imaging
7. Subject participates in a potentially confounding drug or device trial during the course of the study.
8. Subject meets an exclusion criteria according to national law (e.g. age, pregnant woman, breastfeeding woman)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Full aneurysm occlusion 12 <br/ ><br>months after flow diverter placementTimepoint: 12 months after flow diverter placement
- Secondary Outcome Measures
Name Time Method Full aneurysm occlusion 6 <br/ ><br>months after flow diverter placementTimepoint: 6 months after flow diverter placement