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Physio-Anatomy Clinical Data Collection Study

RecruitingObservational study

Who can join

Ages 18 and older · All sexes

Full 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

About the study

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.

What is being tested

Sponsor: Gentuity, LLC · Participants: 150 · Started: Mar 14, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05312164

Locations in the U.S.

CaliforniaVeteran's Administration Palo Alto, Palo Alto
FloridaTampa General Hospital, Tampa
GeorgiaAtlanta VA Medical Center, Decatur
MassachusettsBeth Israel Deaconess Medical Center, Boston
MinnesotaMinneapolis VA Medical Center, Minneapolis
OhioThe Christ Hospital, Cincinnati

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.