Collection of data on coronary artery procedures
Official title: Physio-Anatomy Clinical Data Collection Study
Run by Gentuity, LLC · NCT05312164 · Data updated 2026-11-12
This study is collecting information on different heart procedures to see how they work for patients with suspected coronary disease who are getting treatment through a catheter.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Gentuity, LLC Industry-sponsored |
| Locations | 6 sites (Palo Alto, California and 5 other locations) |
| Status | Recruiting |
| Started | March 14, 2022 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | March 20, 2025 |
| Trial ID | NCT05312164 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old who are scheduled for PCI and have clinical indications for coronary diagnostics.
✕Probably not a fit
Patients with acute myocardial infarction, severe hemodynamic instability, or other significant health issues may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to collect data on three types of interventional procedural techniques used during cardiac catheterization for patients with suspected coronary disease. It utilizes FDA-cleared technologies, including coronary angiography, pressure guidewires, and HF-OCT imaging systems, to evaluate coronary artery conditions. The study focuses on patients who are candidates for percutaneous coronary intervention (PCI) and will assess the physiological parameters of coronary lesions during standard clinical practice.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of coronary stenosis and improve patient outcomes through better diagnostic techniques.
How similar studies have gone: Other studies using similar imaging and physiological assessment techniques have shown promise in improving coronary artery evaluations.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Veteran's Administration Palo Alto
Palo Alto, California, United States Recruiting -
Tampa General Hospital
Tampa, Florida, United States Recruiting -
Atlanta VA Medical Center
Decatur, Georgia, United States Recruiting -
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States Recruiting -
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States Recruiting -
The Christ Hospital
Cincinnati, Ohio, United States Recruiting
Study contacts
- Study coordinator: Arjun Bhat, MD, MBA
- Email: abhat@gentuity.com
- Phone: 978-202-4108
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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PCI Registry at University Hospital Basel for Complex Coronary Procedures
This registry collects real-world data from adults undergoing percutaneous coronary interventions at University Hospital Basel to see how different treatments like drug-eluting stents, drug-coated balloons, and bioresorbable scaffolds perform in diverse patients.
-
Mobile-based home cardiac rehab to see if it reduces non-calcified coronary plaque
A mobile, at-home cardiac rehabilitation program is being tested to see if it can reduce non-calcified plaque in people with mild to moderate coronary artery narrowing.
-
QFR-guided virtual stenting to optimize PCI before the procedure
We’re testing whether using QFR-based virtual stenting before PCI can improve heart-procedure outcomes compared with standard angiography planning in adults with coronary artery disease.
-
Single versus dual antiplatelet therapy after drug-coated balloon angioplasty in elderly or high-bleeding-risk patients
This study tests whether taking one antiplatelet medicine is as safe and causes less bleeding than taking two medicines for people aged 75 or older, or adults at high bleeding risk, after drug-coated balloon angioplasty for coronary artery disease.
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Evaluating the effects of esmolol in patients with heart attacks
This study tests if giving esmolol early to people having a heart attack can help protect their heart and improve blood flow compared to those who don’t get the treatment.
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AI platform for CT coronary angiography applications
This study is testing a new AI platform that helps doctors quickly and accurately analyze heart scans for patients with coronary artery disease to improve their treatment and care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.