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New treatment option for Unruptured Intracranial Aneurysm
Official title Assessment of the Clinical and Economic Impact of Sim&Size, a Simulation Software for Implantable Devices Used in the Treatment of Intracranial Aneurysms: A Prospective Multicenter Study.
ClinicalTrials.gov ID: NCT07433075
What this study is testing
- What it's testing
- In recent years, endovascular treatment of intracranial aneurysms has seen remarkable growth, now surpassing traditional surgical approaches in terms of frequency of use. However, this transition to endovascular methods is not without its challenges.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients aged ≥18 years planned to be treated endovascularly for unruptured intracranial aneurysms.
- Planned implantable device models is available in the Sim\&Size simulation database and used following their approved indications.
- Affiliated with the French social security system.
- Signed the information and consent form
You likely can't join if
- Patients scheduled to undergo endovascular treatment with stents only
- Patients presenting for treatment of a ruptured aneurysm
- Patients who have already been treated in the planned deployment area and whose previous treatment presents a potential contact with the new implant.
- Giant intracranial aneurysm resulting in poor-quality reconstruction in the potential deployment area of the implant during 3DRA acquisition
- Presence of artifacts on the 3DRA in the potential deployment area of the implant
- Patients with multiple aneurysms whose treatment is planned during a single procedure and who require separate individual therapeutic strategies...
See the full eligibility criteria
- Patients aged ≥18 years planned to be treated endovascularly for unruptured intracranial aneurysms.
- Planned implantable device models is available in the Sim\&Size simulation database and used following their approved indications.
- Affiliated with the French social security system.
- Signed the information and consent form
- Patients scheduled to undergo endovascular treatment with stents only
- Patients presenting for treatment of a ruptured aneurysm
- Patients who have already been treated in the planned deployment area and whose previous treatment presents a potential contact with the new implant.
- Giant intracranial aneurysm resulting in poor-quality reconstruction in the potential deployment area of the implant during 3DRA acquisition
- Presence of artifacts on the 3DRA in the potential deployment area of the implant
- Patients with multiple aneurysms whose treatment is planned during a single procedure and who require separate individual therapeutic strategies. Examples of individual therapeutic strategies excluded from the study...
- Patients for whom pre-planning was performed using Sim\&Cure software prior to patient randomization.
- Pregnant or breastfeeding women.
- Patients under guardianship or conservatorship.
- Emergency situations.
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Bordeaux, France
- Le Kremlin-Bicêtre, France
- Marseille, France
- Paris, France
- Reims, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Bordeaux, France; Le Kremlin-Bicêtre, France; Marseille, France; Paris, France; Reims, France. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.