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

NCT05831202 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 279

Last updated 2026-01-16

No results posted yet for this study

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.

Conditions

  • Intracranial Aneurysm

Interventions

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.

Sponsors & Collaborators

  • Galaxy Therapeutics INC

    lead INDUSTRY

Principal Investigators

  • David Altschul, MD · Montefiore Health System

  • Brian Jankowitz, MD · JFK University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-06
Primary Completion
2026-09-10
Completion
2030-09-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05831202 on ClinicalTrials.gov