The Use of p48/64 MW HPC Flow Modulation Device in the Treatment of Wide-necked Intracranial Aneurysms

Conditions: Hemorrhagic Stroke, Aneurysm, Intracranial, Saccular Aneurysm, Fusiform Aneurysm, Brain Aneurysm

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: NA

Enrollment: 214

Sponsor: phenox Inc.

Summary

To determine safety and effectiveness of the p48 MW HPC and p64 MW HPC Flow Modulation Device in the treatment of wide-necked intracranial aneurysms.

Eligibility Criteria

Inclusion Criteria: 1. Subject is ≥ 18 years 2. Subject has a mRS ≤2 before the index procedure 3. Subject has an unruptured or recanalized intracranial aneurysm (IA). The subject may also have a previous ruptured aneurysm, provided rupture of this aneurysm has occurred more than 30 days from the index procedure. The IA must have the following characteristics below: 1. Saccular or fusiform morphology 2. Located in the internal carotid artery and its branches 3. Aneurysm neck ≥4 mm or dome-to-neck ratio \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07143019). StuddyBuddy aggregates publicly available trial information.