Vis-Rx Prime Micro-Imaging Catheter Study

Gentuity, LLC34 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Coronary Artery Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (3)

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

St. Francis Hospital and Heart Center

Roslyn, New York, United States

Lindner Research Center at The Christ Hospital

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Technical Performance

Clear Image Length of the acquired HF-OCT image during each pullback during a percutaneous coronary intervention procedure

Time frame: During percutaneous interventional procedure, up to 2 hours

Secondary Outcomes

Clinical Performance Endpoint

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 \[Catheter preparation, Catheter deliverability, Image Quality, Overall performance\].

Time frame: During percutaneous interventional procedure, up to 2 hours.

Data from ClinicalTrials.gov

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