Physio-Anatomy Clinical Data Collection Study

Recruiting now

Conditions studied: Coronary Stenosis

In brief

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.

Key facts

Study ID

NCT05312164

Run by

Gentuity, LLC

People needed

150

Starts

2022-03-14

Expected to finish

2025-12-31

Last updated by the study team

2025-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Veteran's Administration Palo Alto — Palo Alto, California, United States (enrolling)
• Tampa General Hospital — Tampa, Florida, United States (enrolling)
• Atlanta VA Medical Center — Decatur, Georgia, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• Minneapolis VA Medical Center — Minneapolis, Minnesota, United States (enrolling)
• The Christ Hospital — Cincinnati, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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