Physio-Anatomy Clinical Data Collection Study

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.

Conditions

Coronary Stenosis

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Study Overview

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Study Details

Study overview

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.

Physio-Anatomy Clinical Data Collection Study

Physio-Anatomy Clinical Data Collection Study

Condition
Coronary Stenosis
Intervention / Treatment

-

Contacts and Locations

Palo Alto

Veteran's Administration Palo Alto, Palo Alto, California, United States, 94304

Tampa

Tampa General Hospital, Tampa, Florida, United States, 33606

Decatur

Atlanta VA Medical Center, Decatur, Georgia, United States, 30033

Boston

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States, 02215

Minneapolis

Minneapolis VA Medical Center, Minneapolis, Minnesota, United States, 55417

Cincinnati

The Christ Hospital, Cincinnati, Ohio, United States, 45219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Gentuity, LLC,

Study Record Dates

2024-12-31