RecruitingNCT05312164
Physio-Anatomy Clinical Data Collection Study
Sponsor
Gentuity, LLC
Enrollment
150 participants
Start Date
Mar 14, 2022
Study Type
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria12
- 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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Interventions
DEVICEHF-OCT Imaging
Subjects undergo HF-OCT imaging of stenosed coronary arteries
DEVICEFFR Pressure Wire
Subjects undergo FFR physiology assessment of stenosed coronary arteries
DEVICEAngiography
Subjects undergo angiography imaging of stenosed coronary arteries
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT05312164
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