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Physio-Anatomy Clinical Data Collection Study

Recruitingn/aAges 18 Years - anyAllGentuity, LLC
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • HF-OCT Imaging
  • FFR Pressure Wire
  • Angiography
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Where

6 sites
Veteran's Administration Palo Alto
Palo Alto, United States
Tampa General Hospital
Tampa, United States
Atlanta VA Medical Center
Decatur, United States
Beth Israel Deaconess Medical Center
Boston, United States
Minneapolis VA Medical Center
Minneapolis, United States
The Christ Hospital
Cincinnati, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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