Study Results
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View full resultsBasic Information
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COMPLETED
312 participants
OBSERVATIONAL
2020-06-26
2021-10-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Standard of Care: Angiography, OCT, FFR, and VFR
Patients will have Pre-OCT Angiography, OCT pullbacks, a FFR measurement and a VFR analysis
ICA (Invasive Coronary Angiography)
Patients will undergo a Pre-PCI Angiography
OCT
OCT pullback images will be collected pre-PCI and (optional) post-PCI procedure
FFR
FFR will be measured
VFR Analysis
VFR will be calculated offline using the OCT pullback images
Interventions
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ICA (Invasive Coronary Angiography)
Patients will undergo a Pre-PCI Angiography
OCT
OCT pullback images will be collected pre-PCI and (optional) post-PCI procedure
FFR
FFR will be measured
VFR Analysis
VFR will be calculated offline using the OCT pullback images
Eligibility Criteria
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Inclusion Criteria
* Patient provides written informed consent
* Scheduled for clinically indicated coronary catheterization with the intent to perform physiologic assessment to guide physician clinical course (in lesions with visual % diameter stenosis 40-90%), if clinically indicated
* Subject is undergoing invasive FFR with Adenosine (high-dose intra-coronary (IC) \[200 μg for the left and or 100 μg for the right coronary artery\] or 140 μg/kg/min for intravenous (IV)) used as hyperemic stimulus
* Clinical presentation with or history of stable angina, unstable angina, or silent ischemia (defined as abnormal stress test or abnormal invasive physiology assessment) that has led to the procedure
Exclusion Criteria
* Presence of acute ST Elevation Myocardial Infarction (STEMI)
* Culprit vessel of Non-ST Elevation Myocardial Infarction (NSTEMI)
* TIMI flow \< Grade 3 at baseline or visible thrombus
* Prior history of coronary artery bypass grafting (CABG)
* Prior heart transplant
* Severe valvular heart disease or history of valve repair or replacement
* Prior history of PCI with stent in target vessel, or target vessel involves in-stent restenosis.
* Target coronary vessel is supplied by major collaterals or is supplying major collaterals to a CTO (chronic total occlusion)
* CTO in the target vessel
* Severe diffuse disease observed in target vessel defined as the presence of diffuse, serial gross luminal irregularities present in the majority of the coronary tree
* Presence of myocardial bridge (MB), regardless of vessel location
* Contraindication for FFR examination or administration of vasodilators
* Known LVEF ≤45%
* Target lesion involves Left Main coronary artery or ostial right coronary artery
* Known renal insufficiency (eGFR \< 30 ml/kg/m\^2 or serum creatinine ≥ 2.5 mg/dL) unless patient is on dialysis
* Heart Failure NYHA Class III or IV
* Subject is pregnant (For a female subject of childbearing potential, a pregnancy test must be performed within 14 days (≤14 days) prior to the index procedure per site standard test)
* Subject has or had active COVID-19 symptoms and/or a positive test result within the prior 2 months
* Participation in another clinical study of an investigational drug or device
* Presence of aneurysm in the target vessel
* Artifact in pre-PCI OCT for the target lesion or in the event of multiple target lesions, artifact in pre-PCI OCT for ALL target lesions
* Target lesion requires any preparation (including but not limited to balloon dilatation, atherectomy, etc.) prior to pre-PCI OCT and physiology measurement, or in case of multiple target lesions, ALL target lesions require-any preparation (including but not limited to balloon dilatation, atherectomy, etc.) prior to pre-PCI OCT and physiology measurement
* Severe vessel tortuosity or calcification in the target vessel such that it is unlikely that the OCT catheter can be delivered
* Target lesion not imaged by OCT or in the event of multiple target lesions, ALL target lesions not imaged by OCT
* Pressure drift of \> 0.03; i.e. Pd and Pa ratio value \< 0.97 or \> 1.03, unless physiology measurements are repeated after re-equalization
* Target lesion or significant CAD beyond 60mm from coronary ostium; i.e. not able to clearly image and capture all disease segment with OCT in 1 run
* Incorrectly done or unsuccessful catheter purge and/or contrast flush
* Presence of plaque rupture and/or intravascular hematoma in target vessel (visual % diameter stenosis ≥ 40%)
* Inability to receive intracoronary nitroglycerin prior to OCT or FFR
* Use of flush media other than radiographic contrast
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Allen Jeremias, MD
Role: PRINCIPAL_INVESTIGATOR
St. Francis Hospital,Roslyn,NY, United States
Locations
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Heart Center Research, LLC.
Huntsville, Alabama, United States
HonorHealth
Scottsdale, Arizona, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
VA Palo Alto Medical Center
Palo Alto, California, United States
UCLA Medical Center Santa Monica
Santa Monica, California, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
The Cardiac & Vascular Institute Research Foundation, LLC
Gainesville, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Atlanta VA Medical Center
Decatur, Georgia, United States
Loyola University Medical Center
Maywood, Illinois, United States
Via Christi Regional Medical Center - St. Francis Campus
Wichita, Kansas, United States
Cardiovascular Research Institute of Kansas
Wichita, Kansas, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
St. Patrick Hospital
Missoula, Montana, United States
New York University Hospital
New York, New York, United States
New York-Presbyterian/Columbia University Medical Center
New York, New York, United States
St. Francis Hospital
Roslyn, New York, United States
Montefiore Medical Center - Moses Division
The Bronx, New York, United States
VA Medical Center Durham
Durham, North Carolina, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Holy Spirit Hospital
Camp Hill, Pennsylvania, United States
Greenville Health System
Greenville, South Carolina, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Austin Heart
Austin, Texas, United States
University of Texas Medical Branch (UTMB)
Galveston, Texas, United States
Memorial Hermann Hospital
Houston, Texas, United States
Countries
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References
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Jeremias A, Maehara A, Matsumura M, Shlofmitz RA, Maksoud A, Akasaka T, Bezerra HG, Fearon WF, Samady H, Samuels B, Rapkin J, Gopinath A, Teraphongphom NT, Buccola J, Ali ZA. Optical Coherence Tomography-Based Functional Stenosis Assessment: FUSION-A Prospective Multicenter Trial. Circ Cardiovasc Interv. 2024 Apr;17(4):e013702. doi: 10.1161/CIRCINTERVENTIONS.123.013702. Epub 2024 Mar 25.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ABT-CIP-10331
Identifier Type: -
Identifier Source: org_study_id
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