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

NCT05831202 | Active Not Recruiting Phase 3 DMC FDA Device

• 1 other identifier: TP0081
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

Interventional Neurology; Intrasaccular Flow Diversion

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with successful aneurysm occlusion at 12 months

  Proportion of subjects with successful aneurysm occlusion at 12 months without parent artery stenosis or retreatment, as determined by independent core lab.

  12 Months

Study Arms (1)

Single arm (The SEAL™ Saccular Endovascular Aneurysm Lattice System)

OTHER

Prospective, US and OUS single-arm, multicenter, interventional study.

Device: The SEAL™ Saccular Endovascular Aneurysm Lattice System

Interventions

The SEAL™ Saccular Endovascular Aneurysm Lattice System DEVICE

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.

Single arm (The SEAL™ Saccular Endovascular Aneurysm Lattice System)

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 80 years of age at the time of screening.
• Unruptured aneurysm requiring endovascular treatment suitable for SEAL device and meet the American Heart Association (AHA) guidelines for management of unruptured aneurysm.5
• Ruptured aneurysm A ruptured aneurysm is defined as a patient with computed tomography (CT), magnetic resonance imaging (MRI), or lumbar puncture (LP) evidence of Subarachnoid Hemorrhage (SAH) attributed to the index aneurysm within the last 60 days. Ruptured aneurysm may be included according to the following criteria:
• Hunt and Hess scale (HHS) of 2 or less at the time of treatment.
• mRS of ≤2 prior to presentation or aneurysm rupture.
• Meet the AHA guidelines for management of ruptured aneurysm.
• The index intracranial aneurysm (IA) to be treated must include the following features:
• Group A (primary analysis group): The Terminus/ bifurcation location:
• mm to 19 mm in equatorial aneurysm width wide neck aneurysm:
• Absolute neck size ≥ 4mm and \< 9mm AND Dome-to-Neck (DN) ratio ≥1 OR Dome- to-Neck (DN) ratio 1 to 2
• Saccular morphology
• Located in the anterior or posterior circulation
• Group B (Expanded Indication): The Sidewall location:
• mm to 19 mm in equatorial aneurysm width wide neck aneurysm:
• Absolute neck size ≥ 4mm and \< 9mm AND Dome-to-Neck (DN) ratio ≥1 OR Dome- to-Neck (DN) ratio 1 to 2

You may not qualify if:

• Aneurysm features unsuitable for endovascular treatment with an intrasaccular device such as fusiform, dissecting pseudo aneurysm, or mycotic aneurysm.
• Aneurysms smaller than 2 mm and larger than 19 mm in dome width.
• Patients with untreated multiple aneurysms \[≥2mm\]. Patient with multiple aneurysms, should have the none index aneurysms treated no less than 60 days prior to enrollment in the SEAL™ IT trial, ≤ 7mm, and not treated with flow diverter or stent assisted endovascular therapy.
• Inability to access target aneurysm with microcatheter due to intracranial atherosclerosis, proximal or intracranial vessel tortuosity or poor aneurysm angle take-off.
• Patients with two 360 degrees loops in the carotid or vertebral arteries.
• Presence of vascular disease or other vascular abnormality that could prohibit access to index aneurysm such carotid stenosis or diminished caliber of the target artery.
• Clinical, angiographic, or CT evidence of central nervous system (CNS) arterial vasculitis, Moyamoya disease, intracranial tumor (except small meningioma \< 3 cm), or any other intracranial vascular malformations.
• Patients with high risk for recurrent ischemic stroke due to previous history of ischemic stroke symptoms such as TIAs, minor, or major strokes within the past 60 days. Other stroke risk factors such as intracranial stenosis or atrial fibrillation.
• Patients with hemodynamic or medical compromise due to medical comorbidities such as severe unstable congestive heart failure (ejection fraction \<30%) or severe chronic obstructive pulmonary disease (COPD) requiring home oxygen.
• Target index aneurysm that has been previously treated and contains devices, implants, or coils that could interfere with correct SEAL™ device placement.
• Subject is pregnant or a lactating female (For females of child-bearing potential, a positive pregnancy test within 7 days of the day of procedure or refusal to use a medically accepted method of birth control for the duration of the study.
• Currently on anticoagulation therapy or has a known blood dyscrasia, coagulopathy, or hemoglobinopathy.
• Currently enrolled in another investigational study or post-market study that could affect the safety and efficacy of aneurysm treatment or interfere with the study follow-up schedule.
• Presence of an acute life-threatening illness requiring treatment.
• Life expectancy of \< 5 years.

Sponsors & Collaborators

• Galaxy Therapeutics INC: lead

Study Sites (6)

Endeavor Health - Northwest Community Hospital

Arlington Heights, Illinois, 60005, United States

Location

Endeavor Health - Evanston Hospital

Evanston, Illinois, 60201, United States

Location

Endeavor Health- Edward Hospital

Naperville, Illinois, 60540, United States

Location

The Cooper Health System

Camden, New Jersey, 08103, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• David Altschul, MD

  Montefiore Health System

  PRINCIPAL INVESTIGATOR

• Brian Jankowitz, MD

  JFK University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: April 26, 2023
• Study Start: August 6, 2024
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): September 10, 2030
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)