SPECTACL: SPECTroscopic Assessment of Coronary Lipid

This study has been completed.
Sponsor:
Information provided by:
InfraReDx
ClinicalTrials.gov Identifier:
NCT00330928
First received: May 26, 2006
Last updated: July 14, 2009
Last verified: July 2009

May 26, 2006
July 14, 2009
January 2006
October 2007   (final data collection date for primary outcome measure)
Spectral Similarity [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Similarity of spectra obtained within the coronary arteries of patients at baseline and spectra obtained from coronary artery autopsy specimens.
Complete list of historical versions of study NCT00330928 on ClinicalTrials.gov Archive Site
  • Review of Lipid Core Plaque of Interest Near Infrared Signals Observed at Baseline in Patients With Stable Angina vs Acute Coronary Syndromes [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Identification of Distinct Near Infrared Spectral Characteristics Associated With Special Coronary Artery Features Identified by Angiography and/or Intravascular Ultrasound and Patient Characteristics [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Clinical Cardiac Events Definitely Attributable to the Study Device That Occur From Enrollment to 7 Days Post Enrollment [ Time Frame: Baseline to 7 day ] [ Designated as safety issue: Yes ]
  • Cardiac Events That Occur Within 1 Year Post Enrollment Will be Examined for Link to Lipid Signals. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Review of lipid-rich plaque NIR signals observed at baseline in patients with stable angina vs ACS
  • Identification of distinct NIR spectral characteristics associated with special coronary artery features identified by angiography and/or IVUS and patient characteristics
  • Clinical Cardiac Events that occur during followup at 1yr.
Not Provided
Not Provided
 
SPECTACL: SPECTroscopic Assessment of Coronary Lipid
Coronary Artery Plaque Characterization by NIR Spectroscopy in Patients Undergoing Elective Percutaneous Coronary Intervention

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).

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 syndromes(unstable 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.

Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Angina Pectoris
  • Angina, Unstable
  • Myocardial Infarction
  • Device: Near Infrared Spectroscopy (NIRS) Imaging
    Near infrared spectroscopic imaging of the coronary artery with an intravascular spectroscopy catheter.
    Other Name: InfraReDx, LipiScan (prototype)
  • Device: intravascular ultrasound (IVUS)
    Ultrasound coronary catheter is positioned on a guidewire that has been placed in the coronary artery.Ultrasound imaging provides structural information about the vessel wall and blockages contained. It takes approximately 5 minutes to prepare, position, and to collect data with the catheter.
    Other Names:
    • Volcano, Revolution
    • Volcano, Eagle Eye
    • Boston Scientific, Atlantis
Experimental: 1
Subjects undergoing elective percutaneous coronary intervention
Interventions:
  • Device: Near Infrared Spectroscopy (NIRS) Imaging
  • Device: intravascular ultrasound (IVUS)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
October 2008
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • >=18yrs and undergoing elective or non-emergent PCI of a de novo native coronary artery lesion
  • Treatment plan (at time of consent and at time of intervention) must be to perform an intervention on no more than 2 lesions, where one is the culprit lesion and the other lesion requires revascularization at the discretion of the treating physician.
  • Target lesion should have "low-risk" characteristics(defined by angiography)
  • Subject must be able to read, understand and sign an approved informed consent form and follow protocol
  • Female subjects of child bearing potential must have a negative serum pregnancy test prior to enrollment

Exclusion Criteria:

  • Evidence of Clinical instability in the 6 hours before the procedure, or at any time during the procedure (72 hours stable post-STEMI)
  • Angiographically Unsuitable Coronary and/or Lesion Morphology in the culprit vessel.
  • A contraindication to anticoagulation or increased risk of bleeding.
  • Clinically significant abnormal laboratory findings
  • Presence of a drug eluting stent in the artery for experimental study prior to NIR measurement, unless all struts are covered by endothelium as documented by IVUS
  • Elective PCI on or through bypass grafts or LIMA grafts
  • Allergy or intolerance to aspirin or clopidogrel
  • Planned use of laser ablation, rotational ablation, brachytherapy, or atherectomy device
  • Enrollment or participation in any other medication trial within the previous 30 days
  • Current enrollment participation or enrolled in another clinical trial
  • Any other factor that the investigator feels would put the patient at increased risk if participating in the protocol
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00330928
0101, CL0101
Yes
Director of Clinical & Regulatory Affairs, InfraReDx Inc.
InfraReDx
Not Provided
Principal Investigator: Sergio Waxman, MD Lahey Clinic, Burlington, MA, USA
InfraReDx
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP