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Intracoronary Imaging With NIRS-IVUS to Characterize Arterial Plaques

Sponsor
Spectrum Health Hospitals (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01694368
Collaborator
(none)
500
Enrollment
1
Location
121
Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To characterize atherosclerotic coronary artery plaques using advanced intra-coronary imaging with a combined near-infrared spectroscopy and intravascular ultrasound catheter before and after percutaneous intervention

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study is being performed to characterize the composition and morphologic characteristics of atherosclerotic coronary artery plaques with intra-coronary near-infrared spectroscopy and intravascular ultrasound in patients undergoing percutaneous coronary intervention.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    500 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Multimodality Advanced Intracoronary Imaging With Near-infrared Spectroscopy and Intravascular Ultrasound to Characterize Coronary Artery Plaques Before and After Percutaneous Intervention
    Study Start Date :
    Nov 1, 2011
    Anticipated Primary Completion Date :
    Oct 1, 2021
    Anticipated Study Completion Date :
    Dec 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. MACCE [5 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Subject is at > 18 years of age

    2. Subject presents to the catheterization laboratory to undergo clinically-indicated, invasive coronary angiography

    3. Subject is willing and able to provide informed written consent

    4. Subject is found to have ≥ 1 severe coronary artery stenosis by invasive angiography and percutaneous coronary intervention is planned for definitive treatment or found to have ≥ 1 intermediate coronary artery stenosis and IVUS planned for lesion assessment

    5. Coronary anatomy is deemed suitable for combined NIRS-IVUS by the interventional cardiologist performing invasive angiography and intervention

    Exclusion Criteria:

    1. Subject is pregnant or suspected to be pregnant

    2. Subject is unable to provide informed consent

    3. Subject has coronary artery anatomy deemed by interventionalist as unsuitable for NIRS-IVUS

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Spectrum Health; Frederik Meijer Heart &Vascular Institute Grand Rapids Michigan United States 49503

    Sponsors and Collaborators

    • Spectrum Health Hospitals

    Investigators

    • Principal Investigator: Ryan D Madder, MD, Spectrum Health Hospitals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ryan Madder, MD, Physician, Spectrum Health Hospitals
    ClinicalTrials.gov Identifier:
    NCT01694368
    Other Study ID Numbers:
    • 2011-285
    First Posted:
    Sep 27, 2012
    Last Update Posted:
    Oct 22, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Ryan Madder, MD, Physician, Spectrum Health Hospitals
    Near infrared spectroscopy; lipid core; vulnerable plaque
    Additional relevant MeSH terms:
    Coronary Artery Disease

    Study Results

    No Results Posted as of Oct 22, 2020