Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2022-03-14
2025-12-31
Brief Summary
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Detailed Description
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* A coronary angiography imaging system to X-ray the coronary arteries for the evaluation of vessel narrowing or blocking.
* Pressure guidewire from one or more manufacturers for the measurement of coronary physiology parameters.
* Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging catheter for imaging and sizing of the stenosed coronary arteries.
Conditions
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Study Design
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CASE_ONLY
OTHER
Study Groups
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Candidates for PCI
Patients undergoing diagnostic cardiac catheterization/PCI.
HF-OCT Imaging
Subjects undergo HF-OCT imaging of stenosed coronary arteries
FFR Pressure Wire
Subjects undergo FFR physiology assessment of stenosed coronary arteries
Angiography
Subjects undergo angiography imaging of stenosed coronary arteries
Interventions
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HF-OCT Imaging
Subjects undergo HF-OCT imaging of stenosed coronary arteries
FFR Pressure Wire
Subjects undergo FFR physiology assessment of stenosed coronary arteries
Angiography
Subjects undergo angiography imaging of stenosed coronary arteries
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Gentuity, LLC
INDUSTRY
Responsible Party
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Locations
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Veteran's Administration Palo Alto
Palo Alto, California, United States
Tampa General Hospital
Tampa, Florida, United States
Atlanta VA Medical Center
Decatur, Georgia, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States
The Christ Hospital
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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003785
Identifier Type: -
Identifier Source: org_study_id
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