Aneurysm Cerebral
Conditions
Keywords
Aneurysm Cerebral, Stroke, Medical Device Treatment
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
Interventions
DEVICEFred X Medical Device Intervention for Aneurysm Treatment with DAPT Therapy.
medial device intervention for aneurysm cerebral.
Sponsors
Jacobs institute
University at Buffalo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Subject has a single untreated target IA.
Exclusion criteria
* Subject with anatomy not appropriate for endovascular treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A thromboembolic event in the territory supplied by the treated artery. | 12 months | A thromboembolic event in the territory supplied by the treated artery. |
Countries
United States
Contacts
CONTACTKevin MacDonald
PRINCIPAL_INVESTIGATORElad Dr. Levy, MD
Jacobs institute
CONTACTCarlos Dr. Pena, PhD
Outcome results
None listed