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SEAL™ ME: Saccular Endovascular Aneurysm Lattice System Multicenter Enrollment Global Registry — SEAL™ ME  

Aneurysm Clinical Trial

Official title:
SEAL™ ME: Saccular Endovascular Aneurysm Lattice System Multicenter Enrollment Global Registry

Clinical Trial Summary

Prospective, international, single-arm, multicenter, registry study. Patients presenting with evidence of Wide Neck unruptured or ruptured intracranial aneurysm (≤ 20 mm in widest diameter) requiring treatment will be enrolled into the study and treated using the SEAL™ System.

Clinical Trial Description

Prospective, international, single-arm, multicenter, registry study. Patients presenting with evidence of Wide Neck unruptured or ruptured intracranial aneurysm (≤ 20 mm in widest diameter) requiring treatment will be enrolled into the study and treated using the SEAL™ System. Immediate post-procedure angiographic findings, clinical presentation, safety, and optional imaging follow-up for each subject will be collected at 24 hours or discharge, 3 months, 6 months, and required primary end point 12 months post-procedure. DSA at 12 months will be required imaging for the primary effectiveness endpoint assessment. Subjects follow up will continue annually for a total of five years post procedure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05880680
Study type Observational [Patient Registry]
Source Galaxy Therapeutics INC
Contact
Status Not yet recruiting
Phase
Start date June 15, 2023
Completion date June 15, 2030
View Details
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