SPECTACL: SPECTroscopic Assessment of Coronary Lipid (SPECTACL)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00330928 |
Recruitment Status :
Completed
First Posted : May 29, 2006
Results First Posted : May 28, 2009
Last Update Posted : October 10, 2016
|
Sponsor:
InfraReDx
Information provided by:
InfraReDx
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic |
Conditions |
Angina Pectoris Angina, Unstable Myocardial Infarction |
Interventions |
Device: Near Infrared Spectroscopy (NIRS) Imaging Device: intravascular ultrasound (IVUS) |
Enrollment | 106 |
Participant Flow
Recruitment Details | Subjects were recruited from patients presenting to the cardiac catheterization laboratory for scheduled elective percutaneous coronary intervention. Subject's medical history and angiographic coronary anatomy were used to evaluate eligibility. |
Pre-assignment Details |
Baseline Characteristics
Outcome Measures
Adverse Events
Limitations and Caveats
Technical limits of the prototype device factored into the data set reduction(28 patients).Data made available to evaluate handling of the device(30 patients) could not be prospectively evaluated for the primary endpoint of Spectral Similarity.
More Information
Results Point of Contact
Name/Title:
Manager of Clinical Research
Organization:
InfraReDx, Inc
Phone:
781-221-0053
EMail:
pshah@infraredx.com
Responsible Party: | Director of Clinical & Regulatory Affairs, InfraReDx Inc. |
ClinicalTrials.gov Identifier: | NCT00330928 History of Changes |
Other Study ID Numbers: |
0101 CL0101 |
First Submitted: | May 26, 2006 |
First Posted: | May 29, 2006 |
Results First Submitted: | January 28, 2009 |
Results First Posted: | May 28, 2009 |
Last Update Posted: | October 10, 2016 |