NCT07761598

Brief Summary

The TERUMO FRED X EARLY FEASIBILITY STUDY (FAST) is a prospective, single-arm investigation.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
28mo left

Started Aug 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Aug 2026Dec 2028

Study Start

First participant enrolled

August 1, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

2.3 years

First QC Date

August 4, 2026

Last Update Submit

August 7, 2026

Conditions

Aneurysm Cerebral

Keywords

Aneurysm CerebralStrokeMedical Device Treatment

Outcome Measures

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.

    12 months

Study Arms (1)

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.

Interventions

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

medial device intervention for aneurysm cerebral.

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

Eligibility Criteria

Age22 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has a single untreated target IA.

You may not qualify if:

  • Subject with anatomy not appropriate for endovascular treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Jacobs Institute

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Intracranial AneurysmStroke

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Study Officials

  • Elad Dr. Levy, MD

    Jacobs institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Dr. Pena, PhD

CONTACT

(716) 888-4814cpena@jacobsinstitute.org

Kevin MacDonald

CONTACT

(716) 888-4814kmacdonald@jacobsinstitute.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2026

First Posted

August 12, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

August 12, 2026

Record last verified: 2026-08

Locations

US(1)