Trials / Recruiting
RecruitingNCT05880680
SEAL™ME: Saccular Endovascular Aneurysm Lattice System Multicenter Enrollment Global Registry
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- Galaxy Therapeutics INC · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SEAL Device | Using standard interventional endovascular techniques, the device is navigated via the push wire delivery system through compatible neurovascular microcatheters to the aneurysm lumen or target site. The device is positioned into its target aneurysm lumen and is electrically detached by the operator with a hand-held, battery-powered detachment handle designed specifically for the SEAL Embolization System. |
Timeline
- Start date
- 2023-10-09
- Primary completion
- 2026-12-31
- Completion
- 2030-06-15
- First posted
- 2023-05-30
- Last updated
- 2025-04-04
Locations
4 sites across 4 countries: Colombia, New Zealand, Pakistan, Spain
Source: ClinicalTrials.gov record NCT05880680. Inclusion in this directory is not an endorsement.