NCT05312164Recruiting
Physio-Anatomy Clinical Data Collection Study
Source: ClinicalTrials.gov · Last updated 20 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 18 Mar 2022
- Start date
- 14 Mar 2022
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Gentuity, LLC
- Diseases
- Coronary artery disease
- NCT number
- NCT05312164
What you commit to
- Study type: Observational
- Planned participants: 150
- From 14 Mar 2022 to the primary completion date, 31 Dec 2025
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior heart transplant.
Other illness
- Presence of acute ST Elevation Myocardial Infarction (STEMI) at the time of the cath lab procedure.
- Heart Failure NYHA Class IV.
- Severe valvular heart disease.
- Acute renal failure based on diagnostic practice of the treating physician at time of screening.
- Patient has other co-morbid condition(s) that, in the opinion of the Investigator, could limit their
Other
- Contraindication for FFR examination or administration of vasodilators.
- Bacteremia or sepsis.
- Major coagulation system abnormalities.
- Severe hemodynamic instability or shock.
- Patient is pregnant.
- Patient is currently enrolled in another clinical study that may impact the results of this study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| The Christ Hospital Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Atlanta VA Medical Center Coordinator of this site? Confirm its status | Decatur | United States | Recruiting |
| Minneapolis VA Medical Center Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| Veteran's Administration Palo Alto Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
| Tampa General Hospital Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.