- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05686733
Pre-SEAL™IT: Saccular Endovascular Aneurysm Lattice System First In Human Interventional Trial (Pre-SEAL™IT)
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:
- EU CE Mark labelling
- US FDA Investigational Device Exemption (IDE) approval support of PMA approval.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mary S Patterson
- Phone Number: 16143571718
- Email: mary@galaxytherapeutics.com
Study Contact Backup
- Name: Osama O Zaidat, MD, MS
- Email: szaidat@galaxytherapeutics.com
Study Locations
-
-
Antioquia
-
Medellin, Antioquia, Colombia
- Clinicas Las Americas
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 20 to 80 years of age at the time of screening
Evidence of a single unruptured aneurysm requiring treatment. If there is evidence of an additional aneurysm requiring treatment, the secondary aneurysm must also be treatable using a SEAL™ System Device, either during a single procedure or consecutive procedures.
In these instances, no additional implanted devices are permissible except for as medically required for patient safety.
- Ruptured aneurysms may be included according the following criteria: The subject is neurologically stable with a Hunt and Hess scale of 3 or less at the time of treatment
- Modified Disability Scale (mRS) of ≤2 prior to presentation or rupture
The index intracranial aneurysm (IA) to be treated must include the following features:
- Aneurysm features suitable for endovascular treatment with an intrasaccular device per the treating interventionist.
- Saccular morphology
- Located at a bifurcation, terminus, or sidewall in the anterior or posterior circulation
- 3mm-25mm in dome diameter
- Narrow or wide-neck aneurysm with neck size ≥ 4mm or Dome-to-Neck (DN) ratio < 2
- Aneurysm treatment does not require the preplanned use of any additional implanted devices
- Subject is able to maintain compliance with all aspects of screening, evaluation, treatment, and post-procedure follow-up schedule
- Baseline mRS of 0-1 for unruptured cases
- Ability to obtain written informed consent from subject prior to the initiation of any study procedures
- Subject has been approved for inclusion by Galaxy Therapeutics INC. clinical affairs team.
Exclusion Criteria:
- Aneurysm features unsuitable for endovascular treatment with an intrasaccular device such as fusiform, dissecting pseudo aneurysm, or mycotic aneurysm.
- Aneurysms smaller than 3mm and larger than 25mm in dome diameter.
- Inability to access target aneurysm with microcatheter due to intracranial atherosclerosis, vessel tortuosity or poor aneurysm angle take-off.
- 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.
- Proximal vessel tortuosity or morphology that could prohibit access to target aneurysm
- Clinical, angiographic, or CT evidence of CNS arterial vasculitis, moyamoya disease, intracranial tumor (except small meningioma), or any other intracranial vascular malformations
- Patients with high risk for recurrent ischemic stroke due to previous history of intracranial ischemic stroke symptoms such as transient ischemic attacks (TIAs), minor, or major strokes within the past 60 days
- Patients with hemodynamic or medical compromise due to medical comorbidities such as severe unstable congestive heart failure (ejection fraction <30%) or severe COPD requiring home oxygen.
- Modified Rankin Scale (mRS) score of ≤ 2 prior to presentation or acute rupture (as applicable)
- SAH from non-index aneurysm or any other intracranial hemorrhage within the past 60 days
- Target aneurysm 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
- Hypersensitivity that cannot be medically controlled to any component of the SEAL™ System, procedural materials, or medications commonly used during the procedure
- 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
- Subject has an uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the study
- Subject is a prisoner or member of other vulnerable population
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Single arm (The SEAL™ Saccular Endovascular Aneurysm Lattice System)
First In Human (FIH), prospective, single-arm, multicenter, interventional study.
|
Endovascular treatment of target aneurysm using the Saccular Endovascular Aneurysm Lattice (SEAL) device.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Safety Endpoint
Time Frame: Procedure through 12 Months
|
Subject Safety will be considered a failure upon meeting any of the following primary safety criteria:
|
Procedure through 12 Months
|
Primary Efficacy Endpoint
Time Frame: Procedure through 12 Months
|
Proportion of subjects with aneurysm occlusion adjudicated by independent core lab based on satisfaction of the following 3 criterion:
|
Procedure through 12 Months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Boris Pabón, MD, Angiosur
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TP0068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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