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NCT07073118

Safety and EffecTiveness of the Silk Vista Flow DiverteR in the TrEatment of Unruptured IntracrAnial AneurysMs

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

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. 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2025-09

Completion Date

2027-12

Last Updated

2025-07-18

Healthy Volunteers

Conditions

Ruptured and Unruptured Intracranial Aneurysms

Interventions

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

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

Locations (1)

CHU Bordeaux

Bordeaux, France