Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device

Launched by MICROVENTION-TERUMO, INC. · Apr 7, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the long-term safety and effectiveness of a device called the WEB Device, which is used to treat a specific type of brain condition called wide neck bifurcation intracranial aneurysms. These aneurysms are bulges in blood vessels in the brain that can be fragile and may cause serious health issues. The researchers want to see how well the device works at closing these aneurysms over one year after treatment.

To participate in this study, you need to be an adult (18 years or older) with either a ruptured or unruptured aneurysm that needs treatment. You'll need to provide written consent before any procedures are done. However, if you have certain medical conditions that could make you at high risk for strokes or if you've had recent bleeding in your brain, you may not be eligible to join. If you take part, you can expect to be monitored closely for any changes in your condition and to undergo imaging tests to evaluate how well the treatment is working over time.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Patient must be ≥ 18 at the time of screening
• • Patient must have a single ruptured or unruptured IA requiring treatment
• • Patient must sign and date an IRN approved written informed consent prior to initiation of any study procedures
• Key Exclusion Criteria:
• • Patient has an IA with characteristics unsuitable for endovascular treatment
• • Patient has conditions placing them at high risk for ischemic stroke or has exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 30 days
• • Patient has had an SAH from a non-index IA or other intracranial hemorrhage within 90 days
• • Patient index IA was previously treated
• • Patient is pregnant