Clinical Feasibility Evaluation of the Gentuity HF-OCT Imaging System With Vis-M Micro-Imaging Catheter
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HF-OCT Imaging System with Vis-M Micro-Imaging Catheter.
- Who it may be relevant to
- Registry conditions: Anatomy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Argentina
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Device HF-OCT Imaging System with Vis-M Micro-Imaging Catheter
Subjects undergo HF-OCT imaging of the desired intravascular segement
Primary outcome measures
- Device Safety [Time frame: 7 days]
Secondary outcome measures (2)
- Clinical performance [Time frame: 1 day]
- Technical performance [Time frame: 1 day]
Eligibility criteria
Inclusion criteria
- Patients who are electively scheduled for either a follow-up cerebral angiogram or a diagnostic angiogram and may be candidates for a neuroendovascular procedure
- Patients that present with a Modified Rankin Score (mRS) ≤3
- Patients 18 years of age or older
- Patients willing and able to provide written informed consent to participate in evaluation
Exclusion criteria
- Patients with serious concurrent medical conditions including bacteremia or sepsis, acute renal failure at the time of the procedure, and major coagulation system abnormalities that in the opinion of the investigator could significantly increase risk
- Pregnant
- Patient has a known hypersensitivity to contrast media
- Patients undergoing an urgent or emergent neurointerventional procedure
- Patients that present with a Modified Rankin Score (mRS) ≥4
- Patients that present with an unresolved spontaneous subarachnoid hemorrhage and/or intracranial hemorrhage
- Participation in another clinical trial of an investigational drug or device
- Patient has existing Flow Re-Direction Endoluminal Device (FRED®) System
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Other
Study locations
Argentina · 1 center
- Clínica La Sagrada Familia — Buenos Aires
Identifiers
NCT: NCT06078878 · 003818