An observational study in Ruptured and Unruptured Intracranial Aneurysms, sponsored by University Hospital, Bordeaux. Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-18.
Sponsored by University Hospital, Bordeaux · Observational
Intracranial aneurysms (IA) are abnormal outpouchings of cerebral arteries' walls that occur mostly in arteries found in the Circle of Willis and the middle cerebral artery bifurcation with a risk of rupture leading to subarachnoid hemorrhage (SAH) and potentially death. If IA is treated before rupture, survival rates improve dramatically. The IA can be treated with endovascular technique (coiling or stenting). Specifically, the parent artery reconstruction with a flow-diverter stent allows the treatment of a wide range of aneuryms with high rate of aneurysm occlusion. However, during follow-up, up to 15% of FD present deformities, associated with increased morbidity secondary to implant. This phenomenon is not predictable and its mechanism remains unexplained. The objective of this STREAM study is to generate longitudinal clinical and imaging data on the Silk Vista to further evaluate its efficacy and safety in the treatment of unruptured IA, and in particular, to assess and understand the impact of morphological changes over time associated with this device
Intracranial aneurysms (IA) are abnormal outpouchings of cerebral arteries' walls. IA prevalence ranges between 1.8% and 8% in adults, with an approximately equal male/female distribution and a mean age of 50 years at first detection. They predominantly occur in arteries found in the Circle of Willis and the middle cerebral artery bifurcation (85%). The primary concern after discovery of an unruptured IA (UIA) is the risk of rupture leading to subarachnoid hemorrhage (SAH) and potentially death. The aneurysmal SAH has been associated with up to 50% mortality, whereas approximately 30% of survivors are left with severe neurological and/or neurocognitive deficits, resulting in a significant public health burden. Given the evidence that when an IA is treated before rupture, survival rates improve dramatically, identification of aneurysms, specifically those at risk of rupture, and availability of effective treatment strategies, are essential for improving the clinical outcomes of these patients. The IA treatment management includes surgery (neurosurgical clipping has been the gold standard) or endovascular methods. However, over the past decade, the endovascular options to manage IA, ruptured or not, have rapidly evolved, making the treatment of IA less invasive and increasingly more successful. In endovascular technique, a parent artery reconstruction is realized with a flow-diverter stent. Following their specific characteristics, flow diverters (FD) were initially designed to treat giant and large. When comparing FD to the other endovascular techniques (coiling or stenting), FD have been shown to have a higher rate of occlusion for large aneurysms. However, during follow-up, up to 15% of FD present a stenosis that may affect their extremities (known as " fishmouth " stenosis) or their mid-segment (" stent collapse "). The deformities are associated with increased morbidity secondary to implant. This phenomena is not predictable and its mechanism remains unexplained. The DFT (drawn-filled tubing with platinum) technology used for braiding the latest generation of FD stents, including the SILK VISTA stent, may potentially contribute to this phenomenon. Data from an independent and comprehensive evaluation are needed to confirm safety and efficacy in this context. The Silk Vista SDF (BALT, Montmorency, France) is intended for the treatment of IA. The objective of this STREAM study is to generate longitudinal clinical and imaging data on the Silk Vista to further evaluate its efficacy and safety in the treatment of UIA, and in particular to assess and understand the impact of morphological changes over time associated with this device.
78 studies on the registry are indexed under Rupture; 17 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 31 observational studies indexed under Rupture.
Browse Rupture studies →University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.
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Patients aged ≥ 18 and ≤ 80 years old, with at least one unruptured intracranial aneurysm intended to be treated with Silk Vista
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients aged ≥ 18 and ≤ 80 years old, with at least one unruptured intracranial aneurysm intended to be treated with Silk Vista
Device: Endovascular treatment with placement of a flow-diverting stent
Flow diverter stents (FDS) are braided stents with specific porosity that promotes the flow redirection within the parent vessel and outside the aneurysm sac, and the endothelialization. The FDS placed in the parent artery and covering the aneurysm sac will promote the intra-aneurysmal blood stagnation and parent vessel wall healing. All of these promoting, the aneurysm's thrombosis and ist regression
Correlation between stent modification with the geometry of the parent artery and the aneurysm and the dimensions of the stent.
Correlation between stent modification (shortening and/or degree and location of stenosis) with the geometry of the parent artery and the aneurysm and the dimensions of the stent (diameter and length).
Time frame: Month 12
Complete occlusion rate
Complete occlusion rate of the intracranial aneurysm. Intracranial aneurysm occlusion is measured using three scales : * Cekirge-Saatci : 5 levels from Class 1 (Complete occlusion of the aneurysm sac) to class 5 (Stable remodeling with flow modification) * O'Kelly-Marotta : including Aneurysm filling (from A-total filling (\>95%) to D-no filling (0%)) and Stasis phase (from 1-no stasis (arterial phase clearance, before capillary phase) to 3-significant stasis (persistent contrast at venous phase)) * Modified Raymond-Roy : from class I (complete obliteration) to class III (residual aneurysm)
Time frame: Month 12
Occlusion level
Occlusion level of the treated aneurysm (acceptable (90-100%); without stenosis of the parent artery (\>50%). Intracranial aneurysm occlusion is measured using three scales : * Cekirge-Saatci : 5 levels from Class 1 (Complete occlusion of the aneurysm sac) to class 5 (Stable remodeling with flow modification) * O'Kelly-Marotta : including Aneurysm filling (from A-total filling (\>95%) to D-no filling (0%)) and Stasis phase (from 1-no stasis (arterial phase clearance, before capillary phase) to 3-significant stasis (persistent contrast at venous phase)) * Modified Raymond-Roy : from class I (complete obliteration) to class III (residual aneurysm)
Time frame: Month 12
Successful stent deployment
Successful stent deployment at the target site, defined as the absence of implantation of a new device at the target aneurysm, endovascular treatment, additional stenting, or stent stenosis
Time frame: Month 12
disabling stroke
Absence of disabling stroke or death (assessed by a Clinical Events Committee).
Time frame: Month 1, Month 6
Major stroke
Occurrence of a major stroke within 7 days post-procedure (NIHSS +4 compared to baseline
Time frame: Day 7
Minor stroke
Occurrence of a minor stroke within 7 days post-procedure (complete resolution or increase of less than 3 points on the National Institutes of Health Stroke Scale (NIHSS
Time frame: Day 7
Neurological events
Any neurological event (regardless of relationship) leading to clinical deterioration, based on the change in the mRS (modified Rankin Scale) score : If the baseline mRS score is between 0 and 2, a deterioration is considered if it changes between 3 and 5; If the baseline mRS score is between 3 and 5, a deterioration is considered if it increases by one point from the baseline score.
Time frame: Month 12
Morphological changes
Incidence of morphological changes over the stent period (stent stenosis ≥50%).
Time frame: Month 1, Month 6, Mont 12
Parent artery occlusion
Incidence of parent artery occlusion
Time frame: Month 12
Intracranial hemorrhage
Incidence of intracranial hemorrhage (aneurysm-related)
Time frame: Month 1, Month 6, Mont 12
Adverse events
Incidence of adverse events (other)
Time frame: Month 1, Month 6, Mont 12
Plan to share: No
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