Coronary Artery Disease Clinical Trial
Official title:
Lipiscan and Ultrasound Interrogation of Atherosclerotic Coronary Arteries (LUNAR)
The primary objective of this study is to characterize coronary artery blockages as determined by the LipiScan combined NIRS-IVUS catheter using multi-vessel imaging.
This is a prospective, observational, single-center registry that will enroll 100 patients.
All patients presenting to Beaumont Hospital for elective invasive coronary angiography and
possible ad hoc percutaneous coronary intervention balloon angioplasty will be considered for
inclusion. Patients must meet all inclusion and exclusion criteria prior to consent. All
information requested as part of this study will be obtained from clinical data as part of
each subject's standard medical care. Cardiac catheterization and percutaneous coronary
intervention will be performed according to standard guidelines and clinical practice. All
aspects of clinical care of the patient will follow routine standards as determined by
institutional policies, published clinical practice guidelines, and the treating physician.
After completion of routine invasive coronary angiography and upon determining that the
patient has either (1) an epicardial de novo coronary artery lesion of indeterminate severity
(>50% to <70% stenosis) that requires IVUS analysis for further delineation of stenosis
(blockage) severity; or (2) a severe epicardial de novo coronary artery lesion that requires
PCI for definitive treatment, combined NIR-IVUS imaging will be carried out in the
target-vessel. Upon completion of NIRS-IVUS imaging of the target-vessel, percutaneous
intervention will be performed in the standard fashion if deemed clinically appropriate. Upon
completion of target-vessel intervention, NIRS-IVUS imaging will then be repeated in the
target-vessel.
Upon completion of the treatment of the target-vessel, NIRS-IVUS will be performed in any
other major epicardial vessel containing a stenosis ≥30% if deemed appropriate by the
treating cardiologist.
Patients will be carefully monitored throughout their hospital stay and will be followed
either by office visit or by telephone at 6 months (± 7 days); 12 months (± 14 days); 24
months (± 30 days); 36 months (± 30 days); 48 months (± 30 days); and 60 months (± 30 days).
The patient's medical records will be accessed to collect data about medical history and
activities during the course of the study. All data will be collected by using standard case
report forms. Follow up data after discharge will be collected using a phone script
questionnaire . All data forms will include unique study identifiers to protect the
participants personal identity. All data will be recorded in an Excel spreadsheet and kept on
a secure computer requiring password entry.
There are no additional required medical procedures as part of this protocol beyond the use
of the NIRS-IVUS catheter during the index procedure.
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