Physio-Anatomy Clinical Data Collection Study

Study Overview
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Brief Summary
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This is an on-label clinical study design intended for the collection of three different types of interventional procedural data using FDA-cleared cardiac catheterization technologies and drugs, each used according to its product labeling and standard practice of medicine.

Detailed Description
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These devices and drugs are commonly used for patient evaluation during PCI procedures performed by Interventional Cardiologists. The three device technologies used in a single catheterization laboratory visit for assessment of the coronary arteries include: A coronary angiography imaging system to X-ray the coronary arteries for the evaluation of vessel narrowing or blocking. Pressure guidewire from one or more manufacturers for the measurement of coronary physiology parameters. Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging catheter for imaging and sizing of the stenosed coronary arteries.

Official Title
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Physio-Anatomy Clinical Data Collection Study

Conditions
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Coronary Stenosis

Intervention / Treatment
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* Device: HF-OCT Imaging
* Device: FFR Pressure Wire
* Device: Angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients >18 years of age. Patients provide written informed consent. Clinical presentation consistent with suspected coronary disease. Patients who are candidates for PCI and scheduled for coronary diagnostics in the cardiac catheter lab with the intent to perform a physiological assessment for de novo lesions with stenosis, if clinically indicated. Exclusion Criteria: Presence of acute ST Elevation Myocardial Infarction (STEMI) at the time of the cath lab procedure. Contraindication for FFR examination or administration of vasodilators. Bacteremia or sepsis. Major coagulation system abnormalities. Severe hemodynamic instability or shock. Heart Failure NYHA Class IV. Severe valvular heart disease. Prior heart transplant. Acute renal failure based on diagnostic practice of the treating physician at time of screening. Patient is pregnant. Patient is currently enrolled in another clinical study that may impact the results of this study. Patient has other co-morbid condition(s) that, in the opinion of the Investigator, could limit their

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Candidates for PCI<br>Patients undergoing diagnostic cardiac catheterization/PCI. | Device: HF-OCT Imaging<br>* Subjects undergo HF-OCT imaging of stenosed coronary arteries<br>Device: FFR Pressure Wire<br>* Subjects undergo FFR physiology assessment of stenosed coronary arteries<br>Device: Angiography<br>* Subjects undergo angiography imaging of stenosed coronary arteries<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of angiography images, HF-OCT images, and FFR pressure wire data | There are no efficacy or safety outcomes in this study. This study is a simple data collection study to help the sponsor develop next-generation HF-OCT software. Pressure wire data will be paired with HF-OCT images and angiography images for analysis to determine if the HF-OCT imaging technology can predict FFR physiology information from the OCT pullback. | 2 years |