Coronary Artery Disease
Conditions
Brief summary
Post-market clinical evaluation of the Gentuity High-Frequency Optical Coherence Tomography (HF-OCT) System and the Vis-Rx Micro-Imaging Catheter for use in Percutaneous Coronary Intervention (PCI) procedures.
Detailed description
Prospective, single-arm, unblinded, multi-center, post-market clinical evaluation assessing the imaging capabilities of the Gentuity HF-OCT System and the Vis-Rx Micro-Imaging Catheter for use in PCI procedures. Objectives are to evaluate the clinical and technical performance in the target patient population.
Interventions
DEVICEHF-OCT Imaging with the Vis-Rx Micro-Imaging Catheter
Intracoronary HF-OCT imaging of the target lesion(s) during the procedure.
Sponsors
Gentuity, LLC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Willing and able to provide written informed consent to participate * Transluminal interventional procedure for their coronary arteries General
Exclusion criteria
* Bacteremia or sepsis * Major coagulation system abnormalities * Severe hemodynamic instability or shock * Acute renal failure * Disqualified for Coronary Artery Bypass Graft (CABG) surgery * Disqualified for PCI procedure * Currently enrolled in another study to evaluate an investigational device or medication Lesion-Specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical performance | Immediately after the procedure | Operator evaluation of performance via Likert scale |
| Technical performance | Up to 3 months following the procedure | Objective measurement of image clarity of the HF-OCT images by an independent core lab |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete pullbacks | Up to 3 months following the procedure | Percentage of HF-OCT images with maximum clear image length |
Countries
United States
Outcome results
None listed