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NCT Number: NCT07761598

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

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

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Key information

Conditions

Aneurysm Cerebral Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Aneurysm Intracranial Arterial Diseases Nervous System Diseases Stroke Vascular Diseases

Age range

22 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The FAST study is an Early Feasibility Study (EFS), prospective, open-label, single-arm, unblinded, fifteen (n=15) patient investigation

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject has a single untreated target IA.

Exclusion criteria

  • Subject with anatomy not appropriate for endovascular treatment.

Treatment and study plan

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

Device

medial device intervention for aneurysm cerebral.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Carlos Dr. Pena, PhD

CONTACT

[email protected]

(716) 888-4814

Kevin MacDonald

CONTACT

[email protected]

(716) 888-4814

Sponsors and collaborators

Lead sponsor

Jacobs institute

Other

Collaborators

  • University at Buffalo

Registry information

Acronym: FAST

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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