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Pre-SEAL™IT: Saccular Endovascular Aneurysm Lattice System First In Human Interventional Trial — Pre-SEAL™IT  

Aneurysm Clinical Trial

Official title:
Pre-SEAL™IT: Saccular Endovascular Aneurysm Lattice System First In Human Interventional Trial

Clinical Trial Summary

To establish the preliminary safety and effectiveness of the SEAL™ Endovascular Aneurysm Lattice System for the treatment of saccular intracranial aneurysms. The data from this study will be used to support: 1. EU CE Mark labelling 2. US FDA Investigational Device Exemption (IDE) approval support of PMA approval.

Clinical Trial Description

First In Human (FIH), prospective, single-arm, multicenter, interventional study. Patients presenting with evidence of a single unruptured or ruptured aneurysm requiring treatment will be enrolled into the study and treated using the SEAL™ System. Immediate post-procedure angiographic findings, clinical presentation, safety, and imaging follow-up for each subject will be collected at 24 hours, 3 (MRA), 6, 12 and 24-months post-procedure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05686733
Study type Interventional
Source Galaxy Therapeutics INC
Contact
Status Completed
Phase N/A
Start date January 26, 2022
Completion date February 17, 2024
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