Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT07079956
Brief Summary:
To assess the safety and performance of the TUBE device in the endovascular treatment of unruptured, wide-neck or fusiform intracranial aneurysms located on the internal carotid artery (ICA) or its branches
Detailed Description:
This is a prospective, single-arm, multicenter study designed to assess the safety and performance of the TUBE device in the endovascular treatment of unruptured, saccular wide-neck (neck width ≥ 4 mm or dome-to-neck ratio \< 2) or fusiform intracranial aneurysms arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 5.0 mm and located on the ICA or its branches.
Up to 20 eligible patients who present for flow diverter placement, provide informed consent, meet all inclusion crite-ria, and not meet any exclusion criteria will receive treatment with the TUBE device. All participants will be followed for 1 year. Post-procedure, imaging will be repeated at the Day 30, Month 3, 6, and 12 visits.
Study:
NCT07079956
Study Brief:
Protocol Section:
NCT07079956