Aneurysm CerebralFASTNCT07761598
The TERUMO FRED X EARLY FEASIBILITY STUDY (FAST) STUDY.
A study testing Fred X Medical Device Intervention for Aneurysm Treatment with DAPT Therapy. in people with Aneurysm Cerebral, run by Jacobs institute at 1 site in United States.
Trial summary
The TERUMO FRED X EARLY FEASIBILITY STUDY (FAST) is a prospective, single-arm investigation. Read more about this study
- Who is it for?
- Ages 22 to 85 years
- Conditions the study is for
- Aneurysm Cerebral
- What is being tested?
- Fred X Medical Device Intervention for Aneurysm Treatment with DAPT Therapy.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has a single untreated target IA.
Who cannot join
- Subject with anatomy not appropriate for endovascular treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The Jacobs Institute
Buffalo, New York, 14203
Carlos Dr. Pena, PhD, (716) 888-4814, cpena@jacobsinstitute.org
Kevin MacDonald, (716) 888-4814, kmacdonald@jacobsinstitute.org
About this study
The TERUMO FRED X EARLY FEASIBILITY STUDY (FAST) is a prospective, single-arm investigation.
Read the detailed description
The FAST study is an Early Feasibility Study (EFS), prospective, open-label, single-arm, unblinded, fifteen (n=15) patient investigation
- Conditions
- Aneurysm Cerebral
- Being tested
- Fred X Medical Device Intervention for Aneurysm Treatment with DAPT Therapy.
- Keywords
- Aneurysm Cerebral, Stroke, Medical Device Treatment
- Medical subject headings
- Intracranial Aneurysm, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fred X Medical Device Intervention for Aneurysm Treatment with DAPT Therapy.Device
medial device intervention for aneurysm cerebral.
| Study group | Role | What they receive |
|---|---|---|
| Single arm study for a medical device for the FREDX device for aneurysm cerebral treatment with DAPT | Experimental | Not described Receives: Device: Fred X Medical Device Intervention for Aneurysm Treatment with DAPT Therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A thromboembolic event in the territory supplied by the treated artery.
A thromboembolic event in the territory supplied by the treated artery.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysm CerebralStudies 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
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jacobs institute
- Sponsor type
- University, hospital or other
- Collaborators
- University at Buffalo
- Responsible party
- Sponsor
- Investigators
- Elad Dr. Levy, MD, Principal investigator, Jacobs institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761598
- Sponsor's protocol ID
- CIP-010
- Acronym
- FAST
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: It is currently undecided.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The TERUMO FRED X EARLY FEASIBILITY STUDY (FAST) STUDY.
- ClinicalTrials.gov ID
- NCT07761598
- Acronym / sponsor ID
- FAST / CIP-010
- Conditions
- Aneurysm Cerebral
- Keywords
- Aneurysm Cerebral, Stroke, Medical Device Treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Jacobs instituteUniversity, hospital or other
- Collaborators
- University at Buffalo
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 12 Aug 2026 (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.
The TERUMO FRED X EARLY FEASIBILITY STUDY (FAST) is a prospective, single-arm investigation.
Detailed description
The FAST study is an Early Feasibility Study (EFS), prospective, open-label, single-arm, unblinded, fifteen (n=15) patient investigation
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study for a medical device for the FREDX device for aneurysm cerebral treatment with DAPT | Experimental | Device: Fred X Medical Device Intervention for Aneurysm Treatment with DAPT Therapy. |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject has a single untreated target IA.
Key exclusion criteria (1 listed)
- Subject with anatomy not appropriate for endovascular treatment.
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 |
|---|---|---|
| Fred X Medical Device Intervention for Aneurysm Treatment with DAPT Therapy.medial device intervention for aneurysm cerebral. | Device | Single arm study for a medical device for the FREDX device for aneurysm cerebral treatment with DAPT |
Primary outcome
A thromboembolic event in the territory supplied by the treated artery.
Time frame: 12 months
A thromboembolic event in the territory supplied by the treated artery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Undecided. It is currently undecided.
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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.
Elad Dr. Levy, MD principal investigator
Jacobs institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fred X Medical Device Intervention for Aneurysm Treatment with DAPT Therapy. in people with Aneurysm Cerebral, run by Jacobs institute at 1 site in United States.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 12 Aug 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carlos Dr. Pena, PhD ((716) 888-4814, cpena@jacobsinstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A thromboembolic event in the territory supplied by the treated artery. (time frame: 12 months). 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 12 Aug 2026.