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Clinical Trials/NCT07761598
NCT07761598Not yet recruitingNot Applicable

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

Jacobs institute1 site in 1 country15 target enrollmentStarted: August 1, 2026Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
15
Locations
1
Primary Endpoint
A thromboembolic event in the territory supplied by the treated artery.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
22 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Subject has a single untreated target IA.

Exclusion Criteria

  • •Subject with anatomy not appropriate for endovascular treatment.

Arms & Interventions

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

Experimental

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Jacobs institute
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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The TERUMO FRED X EARLY FEASIBILITY STUDY... | Clinical Trial