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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COMPLETED
257 participants
OBSERVATIONAL
2021-02-22
2023-01-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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HF-OCT imaging
Enrolled subjects who meet lesion-specific eligibility criteria and undergo HF-OCT imaging
HF-OCT Imaging with the Vis-Rx Micro-Imaging Catheter
Intracoronary HF-OCT imaging of the target lesion(s) during the procedure.
Interventions
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HF-OCT Imaging with the Vis-Rx Micro-Imaging Catheter
Intracoronary HF-OCT imaging of the target lesion(s) during the procedure.
Eligibility Criteria
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Inclusion Criteria
* Willing and able to provide written informed consent to participate
* Transluminal interventional procedure for their coronary arteries
Exclusion Criteria
* Major coagulation system abnormalities
* Severe hemodynamic instability or shock
* Acute renal failure
* Disqualified for Coronary Artery Bypass Graft (CABG) surgery
* Disqualified for PCI procedure
* Currently enrolled in another study to evaluate an investigational device or medication
* Total occlusion
* Coronary artery spasm
* Large thrombus (visible under angiography)
* Any target vessel which has undergone a bypass procedure
18 Years
ALL
No
Sponsors
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Gentuity, LLC
INDUSTRY
Responsible Party
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Locations
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University of South Florida
Tampa, Florida, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Countries
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Other Identifiers
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003175
Identifier Type: -
Identifier Source: org_study_id
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