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| Name | Class |
|---|---|
| Balt Extrusion | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with unruptured intracranial aneurysm | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular treatment with placement of a flow-diverting stent | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Complete occlusion rate | Complete occlusion rate of the intracranial aneurysm. Intracranial aneurysm occlusion is measured using three scales :
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Omer Eker, MD, PhD | Contact | +33 (0)5 56 79 56 79 | omer.eker@chu-bordeaux.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Bordeaux | Bordeaux | France |
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| 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 :
| 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 | Month 12 |
| disabling stroke | Absence of disabling stroke or death (assessed by a Clinical Events Committee). | Month 1, Month 6 |
| Major stroke | Occurrence of a major stroke within 7 days post-procedure (NIHSS +4 compared to baseline | 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 | 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. | Month 12 |
| Morphological changes | Incidence of morphological changes over the stent period (stent stenosis ≥50%). | Month 1, Month 6, Mont 12 |
| Parent artery occlusion | Incidence of parent artery occlusion | Month 12 |
| Intracranial hemorrhage | Incidence of intracranial hemorrhage (aneurysm-related) | Month 1, Month 6, Mont 12 |
| Adverse events | Incidence of adverse events (other) | Month 1, Month 6, Mont 12 |
| ID | Term |
|---|---|
| D012421 | Rupture |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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