NCT05831202

SEAL™IT: Saccular Endovascular Aneurysm Lattice System Interventional Pivotal Trial

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 279 (estimated)
• Sponsor: Galaxy Therapeutics INC · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To establish the safety and effectiveness of the SEAL™ Saccular Endovascular Aneurysm Lattice system for the treatment of saccular intracranial aneurysms. The data from this study will be used to support a premarket approval (PMA) submission.

Detailed description

Prospective, United States (US) and Outside of the United States (OUS) single-arm, multicenter, interventional study. Patients presenting with evidence of Wide Neck unruptured or ruptured intracranial aneurysm (≤ 19 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. Digital subtraction angiography (DSA) at 12 months will be required imaging for the primary effectiveness endpoint assessment. After the PMA application, subjects follow up will continue annually for a total of five years post procedure.

Conditions

• Intracranial Aneurysm

Interventions

Type	Name	Description
DEVICE	The SEAL™ Saccular Endovascular Aneurysm Lattice System	All adult subjects between 22 and 80 years of age and presenting with an unruptured or ruptured saccular Wide Neck intracranial aneurysm with less or equal to 19 mm in its equatorial width (2mm-19mm range) that in the opinion of the Principal Investigator (PI) requires treatment and suitable candidate for intrasaccular flow diversion treatment, who meet all eligibility criteria, will be considered for study enrollment.

Timeline

• Start date: 2024-08-06
• Primary completion: 2026-09-10
• Completion: 2030-09-10
• First posted: 2023-04-26
• Last updated: 2026-01-16

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study