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This study is a prospective, single arm, unblinded, and open-label study. The study is designed to evaluate the use of the Gentuity Neurovascular Imaging System in patients undergoing elective neurointerventional diagnostic procedures.
Patients undergoing elective, neurointerventional procedures, or patient undergoing follow-up diagnostic procedures who meet all inclusion criteria and none of the exclusion criteria will be considered for enrollment. The study investigates the use of the Gentuity Neurovascular Imaging System as a diagnostic tool for intravascular imaging in the cerebrovasculature. The study evaluates the incidence and severity of device-related adverse events, clinical usability performance and technical performance of imaging quality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurovascular Imaging | Experimental | Use of the Gentuity HF-OCT Imaging System with Vis-M Micro-Imaging Catheter ("Gentuity Neurovascular Imaging System") as a diagnostic tool for intravascular imaging in the cerebrovasculature. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HF-OCT Imaging System with Vis-M Micro-Imaging Catheter | Device | Subjects undergo HF-OCT imaging of the desired intravascular segement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device Safety | Incidence and severity of device-related adverse events. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical performance | Operator evaluation of performance via Likert scale. | 1 day |
| Technical performance | Clear image length (CIL) of the vessel |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sharon Timberlake, MSHS | Contact | (617) 957-1434 | stimberlake@gentuity.com | |
| Arjun Bhat, MD, MBA | Contact | (978) 202-4108 | abhat@gentuity.com |
| Name | Affiliation | Role |
|---|---|---|
| Pedro Lylyk, MD | Clínica La Sagrada Familia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clínica La Sagrada Familia | Recruiting | Buenos Aires | C1428ARJ | Argentina |
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| 1 day |