NCT00330928

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2006

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
8 months until next milestone

Results Posted

Study results publicly available

May 28, 2009

Completed
Last Updated

January 5, 2021

Status Verified

December 1, 2020

Enrollment Period

1.7 years

First QC Date

May 26, 2006

Results QC Date

January 28, 2009

Last Update Submit

December 10, 2020

Conditions

Angina PectorisAngina, UnstableMyocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Spectral Similarity

    Average spectral similarity of the spectra in a complete scan per patient as compared to the autopsy spectral data set.Clinical data was considered similar to autopsy data if average spectral similarity in each scan was \>=67%, on a continuous range of 0%(different) to 100%(identical) similarity.

    Baseline

Secondary Outcomes (4)

  • Review of Lipid Core Plaque of Interest Near Infrared Signals Observed at Baseline in Patients With Stable Angina vs Acute Coronary Syndromes

    Baseline

  • Identification of Distinct Near Infrared Spectral Characteristics Associated With Special Coronary Artery Features Identified by Angiography and/or Intravascular Ultrasound and Patient Characteristics

    Baseline

  • Clinical Cardiac Events Definitely Attributable to the Study Device That Occur From Enrollment to 7 Days Post Enrollment

    Baseline to 7 day

  • Cardiac Events That Occur Within 1 Year Post Enrollment Will be Examined for Link to Lipid Signals.

    1 year

Study Arms (1)

1

EXPERIMENTAL

Subjects undergoing elective percutaneous coronary intervention

Device: Near Infrared Spectroscopy (NIRS) ImagingDevice: intravascular ultrasound (IVUS)

Interventions

Near Infrared Spectroscopy (NIRS) ImagingDEVICE

Near infrared spectroscopic imaging of the coronary artery with an intravascular spectroscopy catheter.

Also known as: InfraReDx, LipiScan (prototype)
1
intravascular ultrasound (IVUS)DEVICE

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.

Also known as: Volcano, Revolution, Volcano, Eagle Eye, Boston Scientific, Atlantis
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>=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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Duke Medical Center

Durham, North Carolina, 27705, United States

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Related Publications (1)

  • Waxman S, Dixon SR, L'Allier P, Moses JW, Petersen JL, Cutlip D, Tardif JC, Nesto RW, Muller JE, Hendricks MJ, Sum ST, Gardner CM, Goldstein JA, Stone GW, Krucoff MW. In vivo validation of a catheter-based near-infrared spectroscopy system for detection of lipid core coronary plaques: initial results of the SPECTACL study. JACC Cardiovasc Imaging. 2009 Jul;2(7):858-68. doi: 10.1016/j.jcmg.2009.05.001.

    PMID: 19608137RESULT

MeSH Terms

Conditions

Angina PectorisAngina, UnstableMyocardial Infarction

Interventions

Spectroscopy, Near-InfraredDiagnostic ImagingUltrasonography, Interventional

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsInfarctionIschemiaPathologic ProcessesNecrosis

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesUltrasonographyMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

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.

Results Point of Contact

Title
Director Clinical and Regulatory
Organization
InfraReDx, Inc
pshah@infraredx.com
781-221-0053

Study Officials

  • Sergio Waxman, MD

    Lahey Clinic, Burlington, MA, USA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 26, 2006

First Posted

May 29, 2006

Study Start

January 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2008

Last Updated

January 5, 2021

Results First Posted

May 28, 2009

Record last verified: 2020-12

Locations

CA(1)US(5)