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

Key facts

Who runs it
University Hospital, Bordeaux
Where
Bordeaux, FranceSee the site
Trial code
Status
Not yet recruiting
People taking part
100 people, planned
Started
Sept 2025
Expected to end
Dec 2027
Type of study
Observational
Treatments tested
  • Endovascular treatment with placement of a flow-diverting stent
Record updated
18 July 2025

Who can take part

Age
18 years to 80 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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 take part

  • 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
  • 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
  • Chronic anticoagulation therapy is ongoing or known coagulopathy exists
  • 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)
  • Presence of intracranial atherosclerotic disease
  • Presence of intracranial mass (tumor, except meningioma, abscess, or other infection), non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm
  • Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at a point of vessel bifurcation
  • Has more than one known IA that is anticipated to require treatment within 6 months of the index procedure
  • Patient has a serious or life-threatening comorbidity that could confound study results
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Where in France

  • CHU BordeauxBordeaux, FranceContact: Omer Eker, MD, PhDNo longer taking part

About the trial

What the trial wants to find out

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

The group in the trial

  • 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

    Treatment: Endovascular treatment with placement of a flow-diverting stent

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Fit questions
Built from NCT07073118, who can take part
Record updated
18 July 2025