NCT05312164 · Gentuity, LLC
Physio-Anatomy Clinical Data Collection Study
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Palo Alto, California
- Tampa, Florida
- Decatur, Georgia
- Boston, Massachusetts
- Minneapolis, Minnesota
- Cincinnati, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 20, 2025 · Source of record for eligibility and locations