Clinical trial NCT06685783: Vis-Rx Prime Micro-Imaging Catheter Study
Official title: Vis-Rx Prime Micro-Imaging Catheter Clinical Evaluation Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Disease
Lead sponsor: Gentuity, LLC
Sponsor class: INDUSTRY
First posted: 2024-11-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the cardiac catheterization lab who are candidates for PCI

Brief summary: To study the performance of the Gentuity® HF-OCT 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.

Eligibility criteria: 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 exclusion criteria assessed from angiography are:

* Total occlusion
* Coronary artery spasm
* Large thrombus (as visible under angiography)

Primary outcomes:
measure: Clinical performance
timeFrame: During percutaneous interventional procedure
measure: Technical Performance
timeFrame: During percutaneous interventional procedure
Secondary outcomes:
Other outcomes:
measure: Incidence of Adverse Events
timeFrame: During percutaneous interventional procedure
Locations:
city: Park Ridge
country: United States
facility: Advocate Lutheran General Hospital
state: Illinois
city: Roslyn
country: United States
facility: St. Francis Hospital and Heart Center
state: New York
city: Cincinnati
country: United States
facility: Lindner Research Center at The Christ Hospital
state: Ohio
Study officials:
References: