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Coronary stenting with OCT, NIRS/IVUS for Coronary Artery Disease

Phase 4
Waitlist Available
Led By Ik-Kyung Jang, MD, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured one point in time during cardiac catheterization
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at the time of cardiac catheterization
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at the time of cardiac catheterization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Detection of Lipid Rich Plaque by Near Infrared Spectroscopy (NIRS) Intravascular Ultrasound (IVUS)
Secondary study objectives
Differences in NIRS Parameters Between Deep and Superficial Lipid Assessed by Optical Coherence Tomography (OCT).

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Coronary stenting with OCT, NIRS/IVUSExperimental Treatment1 Intervention
All subjects will have Near Infrared Spectroscopy/Intravascular Ultrasound Imaging performed.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,002 Previous Clinical Trials
13,309,536 Total Patients Enrolled
22 Trials studying Coronary Artery Disease
10,485 Patients Enrolled for Coronary Artery Disease
InfraredxIndustry Sponsor
10 Previous Clinical Trials
4,969 Total Patients Enrolled
6 Trials studying Coronary Artery Disease
3,761 Patients Enrolled for Coronary Artery Disease
Ik-Kyung Jang, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
7 Previous Clinical Trials
3,033 Total Patients Enrolled
3 Trials studying Coronary Artery Disease
24 Patients Enrolled for Coronary Artery Disease
~5 spots leftby Oct 2025
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