Evaluation of a Combined Near Infrared Spectroscopy (NIRS) and Intravascular Ultrasound (IVUS) Catheter for Detection of Lipid Rich Plaque

NCT01506960 | Terminated Phase 4 Results

• 1 other identifier: 2010P001608
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn more about lipid rich plaque using Near Infrared Spectroscopy (NIRS)/Intravascular Ultrasound (IVUS) imaging in patients who have had coronary artery stenting and Optical coherence tomography (OCT) imaging.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Detection of Lipid Rich Plaque by Near Infrared Spectroscopy (NIRS) Intravascular Ultrasound (IVUS)

  Subjects are presenting for their clinically-indicated cardiac catheterization. NIRS/IVUS imaging will be done at the time of catheterization.

  Measured one point in time during cardiac catheterization

Secondary Outcomes (1)

• Differences in NIRS Parameters Between Deep and Superficial Lipid Assessed by Optical Coherence Tomography (OCT).

  Measured at the time of cardiac catheterization

Study Arms (1)

Coronary stenting with OCT, NIRS/IVUS

EXPERIMENTAL

All subjects will have Near Infrared Spectroscopy/Intravascular Ultrasound Imaging performed.

Device: InfraReDx Lipiscan IVUS

Interventions

InfraReDx Lipiscan IVUS DEVICE

Near Infrared Spectroscopy/Intravascular Ultrasound will be performed following OCT imaging.

Coronary stenting with OCT, NIRS/IVUS

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient Characteristics
• Males and non-pregnant females \> 18 and \< 79 years of age
• Patients referred for diagnostic coronary angiography who are found to have lesions in native coronary arteries which will be treated by percutaneous coronary intervention (PCI) (or patients with known coronary lesions who are referred for planned PCI)
• Able to give written informed consent
• Lesion Characteristics
• Lesion in native coronary artery
• Angiographic stenosis \> 50%
• Reference vessel diameter 2.5 mm - 4.0 mm by visual estimation
• Subjects who have successful PCI and OCT

You may not qualify if:

• Subjects who are unable or unwilling to sign the informed consent form
• Subjects with New York Heart Association (NYHA) class III or IV heart failure or known left ventricular ejection fraction \< 30%
• Subjects who have experienced an ST-elevation myocardial infarction (STEMI) within 72 hours prior to the procedure
• Subjects with hemodynamic or electrical instability (including shock)
• Subjects diagnosed with severe, non-catheter-related coronary artery spasm
• Subjects who are or may be pregnant
• Subjects with known allergies to contrast media
• Subjects with renal failure as defined by estimated Glomerular Filtration Rate (eGFR) \< 60.
• History of Transient Ischemic Attack (TIA) or stroke \< 6 months
• Lesion located in the left main coronary artery
• Lesions that are heavily calcified
• Lesions where OCT cannot be performed due to technical difficulties
• Other lesions that the investigator deems inappropriate for the procedure such as lesions with excessive tortuosity, presence of thrombus, low flow by TIMI grade.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Infraredx: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Iris McNulty
• Organization: Massachusetts General Hospital

imcnulty@partners.org

617 726 2612

Study Officials

• Ik-Kyung Jang, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: January 3, 2012
• First Posted: January 10, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 18, 2013
• Results First Posted: October 18, 2013

Record last verified: 2013-10

Locations

US (1)