MedDataX Logo

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

NCT ID: NCT01506960

Last Updated: 2013-11-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The aims of this study are to:

1. Test the ability of the new NIRS IVUS system to detect lipid pool
2. Evaluate the accuracy of the NIRS IVUS system for localization of lipide rich plaque: superficial vs deep
3. Improve diagnostic accuracy of OCT for detection of lipid using information from NIRS IVUS

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Coronary stenting with OCT, NIRS/IVUS

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

Group Type EXPERIMENTAL

InfraReDx Lipiscan IVUS

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

InfraReDx Lipiscan IVUS

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Patient Characteristics

1. Males and non-pregnant females \> 18 and \< 79 years of age
2. 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)
3. Able to give written informed consent

Lesion Characteristics

1. Lesion in native coronary artery
2. Angiographic stenosis \> 50%
3. Reference vessel diameter 2.5 mm - 4.0 mm by visual estimation
4. Subjects who have successful PCI and OCT

Exclusion Criteria

1. Subjects who are unable or unwilling to sign the informed consent form
2. Subjects with serious co-morbid conditions that in judgment of the investigator preclude inclusion in this study (such as terminal cancer, life expectancy \< 6 months, Liver Function Tests (LFTs) \> 3 times Upper Limit of Normal (ULN), or post-transplant)
3. Subjects with New York Heart Association (NYHA) class III or IV heart failure or known left ventricular ejection fraction \< 30%
4. Subjects who have experienced an ST-elevation myocardial infarction (STEMI) within 72 hours prior to the procedure
5. Subjects with hemodynamic or electrical instability (including shock)
6. Subjects diagnosed with severe, non-catheter-related coronary artery spasm
7. Subjects who are or may be pregnant
8. Subjects with known allergies to contrast media
9. Subjects with renal failure as defined by estimated Glomerular Filtration Rate (eGFR) \< 60.
10. History of Transient Ischemic Attack (TIA) or stroke \< 6 months


1. Lesion located in the left main coronary artery
2. Lesions that are heavily calcified
3. Lesions where OCT cannot be performed due to technical difficulties
4. Other lesions that the investigator deems inappropriate for the procedure such as lesions with excessive tortuosity, presence of thrombus, low flow by TIMI grade.
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Infraredx

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ik-Kyung Jang, MD, PhD

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ik-Kyung Jang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2010P001608

Identifier Type: -

Identifier Source: org_study_id