Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:39 AM
Ignite Modification Date:
2025-12-25 @ 4:39 AM
NCT ID:
NCT07073118
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07073118
Study Brief:
Protocol Section:
NCT07073118