Clinical Trials in the USA / NCT05312164
Recruiting
Observational
Physio-Anatomy Clinical Data Collection Study
NCT05312164 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Coronary Stenosis
Investigational drug(s) / intervention(s)
HF-OCT ImagingFFR Pressure WireAngiography
HF-OCT Imaging: Subjects undergo HF-OCT imaging of stenosed coronary arteries
FFR Pressure Wire: Subjects undergo FFR physiology assessment of stenosed coronary arteries
Angiography: Subjects undergo angiography imaging of stenosed coronary arteries
Study 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.
Eligibility
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 outcome measure(s)
- Collection of angiography images, HF-OCT images, and FFR pressure wire data — 2 years
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.
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| Veteran's Administration Palo Alto | Palo Alto | California | Recruiting |
| Tampa General Hospital | Tampa | Florida | Recruiting |
| Atlanta VA Medical Center | Decatur | Georgia | Recruiting |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | Recruiting |
| Minneapolis VA Medical Center | Minneapolis | Minnesota | Recruiting |
| The Christ Hospital | Cincinnati | Ohio | Recruiting |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05312164 on ClinicalTrials.gov ↗ ← All trials in the USA