Aneurysms SaccularPre-SEAL™ITNCT05686733
Pre-SEAL™IT: Saccular Endovascular Aneurysm Lattice System First In Human Interventional Trial
A study testing SEAL Device in people with Aneurysms Saccular and Aneurysm, Ruptured, run by Galaxy Therapeutics INC at 1 site in Colombia.
Trial summary
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: 1. EU CE Mark labelling 2. US FDA Investigational Device Exemption (IDE) approval support of PMA approval. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Aneurysms Saccular, Aneurysm, Ruptured, Aneurysm
- What is being tested?
- SEAL Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteColombia
- Study dates
- 26 Jan 2022to 17 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Aneurysms Saccular, Aneurysm, Ruptured, Aneurysm
- Being tested
- SEAL Device
- Medical subject headings
- Aneurysm, Aneurysm, Ruptured
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEAL DeviceDevice
Endovascular treatment of target aneurysm using the Saccular Endovascular Aneurysm Lattice (SEAL) device.
| Study group | Role | What they receive |
|---|---|---|
| Single arm (The SEAL™ Saccular Endovascular Aneurysm Lattice System) | Other | First In Human (FIH), prospective, single-arm, multicenter, interventional study. Receives: Device: SEAL Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
Subject Safety will be considered a failure upon meeting any of the following primary safety criteria:
- Any stroke within 72 hours of the procedure or discharge home (if earlier) that results in an increase of 4 or more points on the National Institute of Health Stroke Scale
- Major ipsilateral stroke within 72 hours post-procedure or discharge home (if earlier) to 12-months following treatment
- New subarachnoid hemorrhage related to target aneurysm within 72 hours post-procedure or discharge home (if earlier) to 12-months following treatment
- Death due to neurologic cause related to aneurysm treated from Procedure to 12-months following treatment
Measured: Procedure through 12 Months
Primary Efficacy Endpoint
Proportion of subjects with aneurysm occlusion adjudicated by independent core lab based on satisfaction of the following 3 criterion:
- WEB-IT Occlusion Scale I and II (WOS) post-implantation, at 6 months, and at 12 months
- Raymond Roy Scale I (RRS) post-implantation, at 6 months, and at 12 months
- Technical success defined as the proportion of subjects in whom a SEAL™ System was successfully delivered and deployed at the target aneurysm
Measured: Procedure through 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start26 Jan 2022
- Primary completion17 Feb 2024
- Study completion17 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysms SaccularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model 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.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galaxy Therapeutics INC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boris Pabón, MD, Principal investigator, Angiosur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686733
- Sponsor's protocol ID
- TP0068
- Acronym
- Pre-SEAL™IT
- Status last verified
- Mar 2024
- First submitted
- 30 Dec 2022
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-SEAL™IT: Saccular Endovascular Aneurysm Lattice System First In Human Interventional Trial
- ClinicalTrials.gov ID
- NCT05686733
- Acronym / sponsor ID
- Pre-SEAL™IT / TP0068
- Conditions
- Aneurysms Saccular, Aneurysm, Ruptured, Aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Galaxy Therapeutics INCIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 17 Feb 2024 (actual)
- Study completion
- 17 Feb 2024 (actual)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model 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.
| Arm | Type | Receives |
|---|---|---|
| Single arm (The SEAL™ Saccular Endovascular Aneurysm Lattice System) | Other | Device: SEAL DeviceFirst In Human (FIH), prospective, single-arm, multicenter, interventional study. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
- The index intracranial aneurysm (IA) to be treated must include the following features:
- Aneurysm treatment does not require the preplanned use of any additional implanted devices
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SEAL DeviceEndovascular treatment of target aneurysm using the Saccular Endovascular Aneurysm Lattice (SEAL) device. | Device | Single arm (The SEAL™ Saccular Endovascular Aneurysm Lattice System) |
Primary outcome
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: * Any stroke within 72 hours of the procedure or discharge home (if earlier) that results in an increase of 4 or more points on the National Institute of Health Stroke Scale * Major ipsilateral stroke within 72 hours post-procedure or discharge home (if earlier) to 12-months following treatment * New subarachnoid hemorrhage related to target aneurysm within 72 hours post-procedure or discharge home (if earlier) to 12-months following treatment * Death due to neurologic cause related to aneurysm treated from Procedure to 12-months following treatment
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: * WEB-IT Occlusion Scale I and II (WOS) post-implantation, at 6 months, and at 12 months * Raymond Roy Scale I (RRS) post-implantation, at 6 months, and at 12 months * Technical success defined as the proportion of subjects in whom a SEAL™ System was successfully delivered and deployed at the target aneurysm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boris Pabón, MD principal investigator
Angiosur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEAL Device in people with Aneurysms Saccular and Aneurysm, Ruptured, run by Galaxy Therapeutics INC at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: Procedure through 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.