Status:
NOT_YET_RECRUITING
Interest of a Simulated Procedure Performed on a Printed Model in the Endovascular Treatment of Carotid-sylvian Aneurysms
Lead Sponsor:
University Hospital, Brest
Conditions:
Aneurysm Cerebral
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
It is now considered that 1% to 2% of the French population has an intracranial aneurysm. The major risk of this malformation is essentially the rupture which will lead in 10% of cases to death immedi...
Detailed Description
The indication of a primary preventive treatment by endovascular route will be posed in a multidisciplinary consultation meeting of neurovascular pathology for patients who have accidentally discovere...
Eligibility Criteria
Inclusion
- Patient over 18 years old
- Social security affiliation
- Patient who signed inform consent form
- Patient with an unruptured saccular carotid-sylvian aneurysm of more than 4 mm in long axis and less than 20 mm
- Primary preventive treatment decision validated in CPR
- Patient having benefited from a 3DRA during a previous arteriography dating from less than 6 months, or whose cerebral arteriography is planned less than 2 weeks before the intervention
Exclusion
- Unable or unwilling to come for follow-up appointments
- Weight \> 250kg due to weight limits on the angiographic table
- Allergy to iodinated contrast agents
- Patient with a contraindication to MRI
- Pregnancy, breastfeeding or planning to become pregnant in the following year
- Limited life expectancy \< 1 year
- Patient participating in another clinical study or having completed their participation less than 30 days ago
- Patient under legal protection, Patient under guardianship or curatorship
- Kidney failure, GFR \< 60ml/min/1.73 m2
- Platelets \< 50 x 10 \^ 9/L
- Partially thrombosed aneurysm
- Partially calcified aneurysm
- Recanalized or previously treated aneurysm (coils, stent, clip, flow disrupter)
- Another aneurysm on the same carrier artery already treated (coils, stent, clip, flow disrupter)
- Ruptured aneurysm
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05419661
Start Date
April 1 2024
End Date
January 1 2026
Last Update
February 20 2024
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