Ruptured and Unruptured Intracranial AneurysmsSTREAMNCT07073118
Safety and EffecTiveness of the Silk Vista Flow DiverteR in the TrEatment of Unruptured IntracrAnial AneurysMs
An observational study of Ruptured and Unruptured Intracranial Aneurysms, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ruptured and Unruptured Intracranial Aneurysms
- What is being tested?
- Endovascular treatment with placement of a flow-diverting stent
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2025to Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged ≥ 18 and ≤ 80 years old, with at least one unruptured intracranial aneurysm intended to be treated with Silk Vista
Who may be able to join
- Age ≥ 18 and ≤ 80 years old,
- Patient has at least one unruptured intracranial aneurysm intended to be treated with Silk Vista
- Has an untreated or recanalized, unruptured or previously ruptured aneurysm whose rupture occurred >30 days prior to the index procedure
- Able and willing to comply with study procedures including returning to the study site for imaging exams
- Able and willing to give oral informed consent
Who cannot join
- Any criteria for non- or contraindication to endovascular treatment and/or flow-diverting stent placement (e.g., suspected mycotic aneurysm, including those caused by a left atrial myxoma, systemic bacterial infection, contraindication to antiplatelet drugs (aspirin, clopidogrel/Plavix, ticagrelor, and heparin), local or general anesthesia, allergy to the contrast agent required for treatment by the diversion technique, known severe allergy or hypersensitivity to nickel, titanium, tungsten, or platinum; cost of treatment for an intracranial aneurysm within the last 6 months; and for women, pregnant, or currently breastfeeding)
- Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at a point of vessel bifurcation
- Has vessel characteristics, such as severe tortuosity, stenosis, or morphology that would preclude safe endovascular access to the target aneurysm necessary for treatment with the study device.
- Presence of intracranial atherosclerotic disease.
- Received previous treatment of the target aneurysm or parent artery where it would interfere with the placement or proper apposition of the device
- Subarachnoid hemorrhage unrelated to a ruptured target aneurysm which occurred within 30 days prior to enrollment
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- Intracranial parenchymal hemorrhage occurred within 30 days prior to enrollment
- Major surgery (including previous intracranial implant) occurred within previous 30 days or is planned in the next 6 months after enrollment date
- Has more than one known IA that is anticipated to require treatment within 6 months of the index procedure
- Chronic anticoagulation therapy is ongoing or known coagulopathy exists
- Patient has a serious or life-threatening comorbidity that could confound study results
- Presence of intracranial mass (tumor, except meningioma, abscess, or other infection), non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm
- Participation in any other investigational study which may interfere with collection of valid data under this study or may influence study endpoints Unable to complete study follow up (12 months) due to geographical distance
- Unable to understanding study
- Under legal protection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU Bordeaux
Bordeaux
Omer Eker, MD, PhD, +33 (0)5 56 79 56 79, omer.eker@chu-bordeaux.fr
About this study
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
Read the detailed description
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.
- Being tested
- Endovascular treatment with placement of a flow-diverting stent
- Keywords
- Intracranial aneurism, flow-diverter stent
- Medical subject headings
- Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular treatment with placement of a flow-diverting stentDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Endovascular treatment with placement of a flow-diverting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Month 12
Secondary outcomes (11)
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)
Measured: 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)
Measured: 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
Measured: Month 12
disabling stroke
Absence of disabling stroke or death (assessed by a Clinical Events Committee).
Measured: Month 1, Month 6
Major stroke
Occurrence of a major stroke within 7 days post-procedure (NIHSS +4 compared to baseline
Measured: 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
Measured: 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.
Measured: Month 12
Morphological changes
Incidence of morphological changes over the stent period (stent stenosis ≥50%).
Measured: Month 1, Month 6, Mont 12
Parent artery occlusion
Incidence of parent artery occlusion
Measured: Month 12
Intracranial hemorrhage
Incidence of intracranial hemorrhage (aneurysm-related)
Measured: Month 1, Month 6, Mont 12
Adverse events
Incidence of adverse events (other)
Measured: Month 1, Month 6, Mont 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study startSep 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ruptured and Unruptured Intracranial AneurysmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Balt Extrusion
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073118
- Sponsor's protocol ID
- CHUBX 2025/023
- Acronym
- STREAM
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No