Summary

A prospective, multicenter, single arm, interventional study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation. The primary effectiveness outcome of the study is adequate intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.

Age: 18 Years and older

Gender: All

Start Date: 08/24/2022

Primary Completion Date (Estimated): 05/01/2026

Study Completion Date (Estimated): 05/01/2030

Accepts Healthy Volunteers: No

Trial Purpose and Description

Eligibility Criteria

Age: 18 Years and older

Gender: All

Accepts Healthy Volunteers: No

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