Ignite Creation Date:
2024-05-06 @ 5:45 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05419661
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2022-05-23
Brief Title:
Interest of a Simulated Procedure Performed on a Printed Model in the Endovascular Treatment of Carotid-sylvian Aneurysms
Sponsor:
University Hospital Brest
Organization:
University Hospital Brest
Study Overview
Official Title:
Evaluation of the Interest of a Simulated Procedure Performed on a Printed Model in the Endovascular Treatment of Carotid-sylvian Aneurysms
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Anev3D
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 immediately in 30 to 50 death within three weeks and in 30 of cases the patients will present a permanent disability The management of this pathology represents today a major health challenge Historically neurosurgery was the discipline of first choice for the treatment of this pathology This consists of clipping the aneurysm by a surgical approach to exclude it from the blood circulation and thus avoid its rupture For many years now interventional neuroradiology has established itself through its minimally invasive and endovascular approach as the reference treatment for ruptured and non-ruptured intracranial aneurysms this is embolization This so-called minimally invasive technique consists of placing directly into the aneurysm using micro-catheters that are navigated under radiological control from the femoral artery turns of plates called coils or prostheses called stent or flow-diverter This technique makes it possible to secure the aneurysm from the inside and thus reduce the risk of rupture Today 95 of patients are treated using this innovative technique and limited intraoperative risks Interventional neuroradiology has constantly known in recent years a set of revolutions and innovations in terms of implantable medical devices IMD allowing to treat more and more patients with excellent clinical results Today the interventional neuroradiologist assisted by the radiographer has a very wide range of IMDs that he can combine with each other depending on the type location size and shape of the aneurysm The role of the manipulator here is to work closely with the neuroradiologist so that he has on the one hand quality images and on the other hand that he can count on a precious ally an expert in IMDs during embolization procedures However the wide choice of medical devices and the complexity of the aneurysms to be treated sometimes make treatment complicated On the day of the cold treatment of the aneurysm ie non-ruptured the technicality of the catheterization and aneurysms spatial conformation complicates the deployment of embolization equipment This then sometimes leads to undesirable events such as intraoperative rupture The very purpose of this study is to be able by means of a 3D printer to print the patients aneurysm from the segmented 3D images obtained during the initial assessment and thus proceed to a simulation of the embolization procedure This pre-operative planning PPO carried out in real conditions aims to anticipate the possible complications that could be encountered on the same day of treatment
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 discovered a carotid-sylvian cerebral aneurysm not ruptured
During the treatment announcement consultation carried out by an interventional neuroradiologist taking place generally less than a month after the staff the latter may propose the study to the patient The investigator gives him the information letter The patient will benefit from a reflection period of one week and will be contacted by telephone by the MERM to validate or not his wish to participate in the study
The random selection of patients is carried out in consultation during the inclusion visit consultation with the MERM The pre-operative course will be carried out according to the usual scheme in the 2 groups Unlike the control group PPO- the PPO group will have a parallel PPO Pre-Planning Operative The intracranial aneurysm embolization treatment procedure will then be performed in both groups
The duration of the study is a maximum of 6 months per participant including a maximum interval of 2 months between the inclusion visit and the treatment usual coverage period between the treatment announcement consultation and the intervention and 4 months of follow-up end-of-study visit at M4
During the treatment announcement consultation carried out by an interventional neuroradiologist taking place generally less than a month after the staff the latter may propose the study to the patient The investigator gives him the information letter The patient will benefit from a reflection period of one week and will be contacted by telephone by the MERM to validate or not his wish to participate in the study
The random selection of patients is carried out in consultation during the inclusion visit consultation with the MERM The pre-operative course will be carried out according to the usual scheme in the 2 groups Unlike the control group PPO- the PPO group will have a parallel PPO Pre-Planning Operative The intracranial aneurysm embolization treatment procedure will then be performed in both groups
The duration of the study is a maximum of 6 months per participant including a maximum interval of 2 months between the inclusion visit and the treatment usual coverage period between the treatment announcement consultation and the intervention and 4 months of follow-up end-of-study visit at M4
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None