Collection of data on coronary artery procedures
Physio-Anatomy Clinical Data Collection Study
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 |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gentuity, LLC Industry-sponsored |
| Locations | 6 sites (Palo Alto, California and 5 other locations) |
| Trial ID | NCT05312164 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are scheduled for PCI and have clinical indications for coronary diagnostics.
Not a fit: Patients with acute myocardial infarction, severe hemodynamic instability, or other significant health issues may not benefit from this study.
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 performed: Other studies using similar imaging and physiological assessment techniques have shown promise in improving coronary artery evaluations.
Eligibility criteria
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 this trial is running
Palo Alto, California and 5 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.