Clinical trial NCT05312164: Physio-Anatomy Clinical Data Collection Study
Official title: Physio-Anatomy Clinical Data Collection Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Stenosis
Lead sponsor: Gentuity, LLC
Sponsor class: INDUSTRY
First posted: 2022-04-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are candidates for PCI who already have a scheduled visit to the cardiac cath lab.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Collection of angiography images, HF-OCT images, and FFR pressure wire data
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Veteran's Administration Palo Alto
state: California
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Decatur
country: United States
facility: Atlanta VA Medical Center
state: Georgia
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Minneapolis VA Medical Center
state: Minnesota
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
Study officials:
References: