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

NCT07073118 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-07-18

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Balt Extrusion

    collaborator INDUSTRY

  • University Hospital, Bordeaux

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07073118 on ClinicalTrials.gov