Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00330928
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2006-05-26
Brief Title:
SPECTACL SPECTroscopic Assessment of Coronary Lipid
Sponsor:
Infraredx
Organization:
Infraredx
Study Overview
Official Title:
Coronary Artery Plaque Characterization by NIR Spectroscopy in Patients Undergoing Elective Percutaneous Coronary Intervention
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPECTACL
Brief Summary:
The purpose of this study is to evaluate a near-infrared NIR spectroscopy system that has been designed to identify the chemical composition of coronary artery plaques in patients undergoing a percutaneous coronary intervention PCI
Detailed Description:
Extensive studies conducted over the past 7 years in autopsy specimens have demonstrated that NIR spectroscopy can identify the plaque structures that are suspected to cause the acute coronary artery syndromesunstable angina myocardial infarction and sudden death
The application of NIR spectroscopy to identify lipid deposition within coronary arteries has shown promising results in preclinical ex vivo studies 14 Infrared spectra are collected as follows light of discrete wavelengths from a laser is directed onto the tissue sample via glass fibers Light scattered from the samples is collected in fibers and launched into a spectrometer The plot of signal intensity as a function of wavelength can be then used to develop chemometric models to discriminate lipid-rich deposits from non-atherosclerotic tissue and from atherosclerotic tissue that is predominantly fibrotic and from blood elements This technique is incorporated into a thin catheter with similar dimensions to an IVUS catheter and the intracoronary dwell time for analysis is similar to the broad experience with established techniques with proven safety such as IVUS
The application of NIR spectroscopy to identify lipid deposition within coronary arteries has shown promising results in preclinical ex vivo studies 14 Infrared spectra are collected as follows light of discrete wavelengths from a laser is directed onto the tissue sample via glass fibers Light scattered from the samples is collected in fibers and launched into a spectrometer The plot of signal intensity as a function of wavelength can be then used to develop chemometric models to discriminate lipid-rich deposits from non-atherosclerotic tissue and from atherosclerotic tissue that is predominantly fibrotic and from blood elements This technique is incorporated into a thin catheter with similar dimensions to an IVUS catheter and the intracoronary dwell time for analysis is similar to the broad experience with established techniques with proven safety such as IVUS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CL0101 | None | None | None |