ClinicalTrials.gg
Not yet recruitingNCT07761598FASTUpdated Aug 12, 2026

The TERUMO FRED X EARLY FEASIBILITY STUDY (FAST) STUDY.

An interventional study of Fred X Medical Device Intervention for Aneurysm Treatment with DAPT Therapy. in Aneurysm Cerebral, sponsored by Jacobs institute. Not yet recruiting at 1 site in United States. Open to participants aged 22 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Jacobs institute · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
22 Years to 85 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Aneurysm Cerebral

Keywords

  • Aneurysm Cerebral
  • Stroke
  • Medical Device Treatment
03

In context

Intracranial Aneurysm

418 studies on the registry are indexed under Intracranial Aneurysm; 119 are open to participants now.

This study's planned enrollment of 15 is below the median of 100 across 207 interventional studies indexed under Intracranial Aneurysm.

Browse Intracranial Aneurysm studies →

Lead sponsor

Jacobs institute is the lead sponsor of 6 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject has a single untreated target IA.

Exclusion criteria

Exclusion Criteria:

  • Subject with anatomy not appropriate for endovascular treatment.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Single arm study for a medical device for the FREDX device for aneurysm cerebral treatment with DAPT

    Device: Fred X Medical Device Intervention for Aneurysm Treatment with DAPT Therapy.

Interventions

  • DeviceFred X Medical Device Intervention for Aneurysm Treatment with DAPT Therapy.

    medial device intervention for aneurysm cerebral.

06

What researchers measure

Primary outcomes

  1. A thromboembolic event in the territory supplied by the treated artery.

    A thromboembolic event in the territory supplied by the treated artery.

    Time frame: 12 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided — It is currently undecided.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07761598
Lead sponsor
Jacobs institute
Collaborators
University at Buffalo
Responsible party
Sponsor
First posted
Aug 12, 2026
Start date
Aug 2026 (estimated)
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Aug 12, 2026

Study contacts

Carlos Dr. Pena, PhD
Contact
cpena@jacobsinstitute.org
(716) 888-4814
Kevin MacDonald
Contact
kmacdonald@jacobsinstitute.org
(716) 888-4814
Elad Dr. Levy, MD
principal investigator · Jacobs institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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