Physio-Anatomy Clinical Data Collection Study
ConditionCoronary Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGentuity, LLC
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- HF-OCT Imaging
- FFR Pressure Wire
- Angiography
Treatment groups
150 Participants
are divided into 1 treatment groupLocations
6California
Veteran's Administration Palo Alto94304, Palo Alto United States
Florida
Tampa General Hospital33606, Tampa United States
Georgia
Atlanta VA Medical Center30033, Decatur United States
Massachusetts
Beth Israel Deaconess Medical Center02215, Boston United States
Sponsors and collaborators
Gentuity, LLC
Lead sponsor
Source ClinicalTrials.gov