Coronary Artery Disease
Conditions
Brief summary
To study the performance of the Gentuity® HF-OCT (High Frequency Optical Coherence Tomography) Imaging System and Vis-Rx Prime® Micro-Imaging Catheter when used to obtain images of coronary arteries in patients who are undergoing cardiac catheterization and are candidates for interventional procedures. The study will evaluate ease of catheter use by physicians using the catheters, image quality and overall performance. The patient's involvement in the study ends when the cardiac catheterization/interventional procedure is completed.
Detailed description
This is a single arm, unblinded, multi-center, clinical evaluation that will be performed at 3 to 5 investigational sites in the United States with subjects who undergo HF-OCT imaging as part of their cardiac catheterization procedure. This study will evaluate a range of device operators (interventional cardiologists) as well as patients and vessels consistent with the product labeling. The operator evaluation will be determined post use of the device using a Likert Grading Scale. Clear Image Length of the acquired HF-OCT image will be measured by an independent core lab. Safety will be monitored through the interventional procedure and Adverse Events that are potentially related to either the device or the procedure will be recorded, evaluated and analyzed.
Interventions
None listed
Sponsors
Gentuity, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients 18 years of age or older * Patients willing and able to provide written informed consent to participate in evaluation * Patients who are candidates for transluminal interventional procedures for their coronary arteries (also known as PCI)
Exclusion criteria
* Bacteremia or sepsis * Major coagulation system abnormalities * Severe hemodynamic instability or shock * Acute renal failure * Disqualified for Coronary Artery Bypass Graft surgery * Disqualified for Percutaneous Coronary Intervention * Patients currently enrolled in another study to evaluate an investigational device or medication * Any target vessel which has undergone a bypass procedure The lesion-specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Performance | During percutaneous interventional procedure, up to 2 hours | Clear Image Length of the acquired HF-OCT image during each pullback during a percutaneous coronary intervention procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Performance Endpoint | During percutaneous interventional procedure, up to 2 hours. | Clinical performance of the Gentuity HF-OCT Imaging System with the Vis-Rx Prime Micro-Imaging Catheter in a real-world setting as determined by the clinical operator using a Likert Grading Scale (1-5 scale; 1=unacceptable, 5= excellent) for each of the 4 measures \[Catheter preparation, Catheter deliverability, Image Quality, Overall performance\]. |
Countries
United States
Participant flow
Recruitment details
Prospective, Single Group, Unblinded, Multicenter
Pre-assignment details
A total of 90 subjects consented of which 56 were screen failures as a result of not meeting inclusion/exclusion criteria. Of the remaining 34 enrolled, 32 subjects completed the HF-OCT (High Frequency Optical Coherence Tomography) imaging. The remaining two subjects met all inclusion/exclusion and lesion specific criteria, however could not be imaged due to catheter malfunctions prior to HF-OCT Imaging. These two subjects were categorized as "Enrolled-not completed".
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 66.5 Years STANDARD_DEVIATION 10.6 |
| Diabetes demographic Diabetes demographic | 24 Participants |
| Diabetes demographic Hypertension demographic | 27 Participants |
| Region of Enrollment United States | 32 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 32 |
| other Total, other adverse events | 1 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
None listed