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Device

IVUS-Guided PCI for Atherosclerosis (IMPROVE Trial)

N/A

Recruiting

Led By Ronald Waksman, MD

Research Sponsored by Medstar Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stable angina, unstable angina, or non-ST Elevation myocardial infarction (NSTEMI), undergoing PCI of a single or multivessel coronary artery stenosis

PCI performed with either angiography alone, or IVUS guidance used

Must not have

Planned revascularization as a staged procedure

Subjects with acute ST elevation myocardial infarction (STEMI), or cardiogenic shock

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Summary

This trial is looking at whether or not using IVUS to guide percutaneous coronary intervention (PCI) will reduce recurrent events after PCI.

Who is the study for?

This trial is for adults over 18 with stable or unstable angina, or NSTEMI, who need PCI for complex coronary artery blockages. Eligible patients have conditions like chronic total occlusion, in-stent restenosis, severe calcification, long lesions, or bifurcation lesions. Those with recent fibrinolytic therapy use, planned staged revascularization, acute STEMI or shock are excluded.

What is being tested?

The study tests if using an IVUS-guided method to place a Resolute Onyx Drug Eluting Stent improves outcomes in complex heart vessel blockages compared to the standard angiography approach. The IVUS uses an Eagle Eye Platinum digital catheter and may include SyncVision technology.

What are the potential side effects?

Possible side effects from the procedure could include bleeding at the catheter insertion site, infection risk increase due to stent placement and reactions related to imaging equipment such as discomfort or allergic reaction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a type of chest pain or minor heart attack and am getting a procedure to open my heart's arteries.

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My heart procedure was guided by imaging or ultrasound.

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My heart stent was placed in a very complex or high-risk part of my heart.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am scheduled for a planned procedure to restore blood flow.

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I have had a severe heart attack or experienced heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

IVUS core lab measures final PCI Minimum Stent Area

Target vessel failure (TVF) outcomes at 12 months defined as the composite of cardiac death, target vessel related-myocardial infarction (MI), and ischemia-driven target vessel revascularization.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: IVUS guided PCIActive Control5 Interventions

Patients will receive a pre-PCI IVUS, IVUS guided stent sizing and optimization per study protocol, post-PCI IVUS

Group II: Angiographic-guided PCIPlacebo Group4 Interventions

Patients will receive angiography guided PCI and angiographic optimization per local standard practice, as well as a post-PCI IVUS blinded to the investigator

0 / 6Eligibility criteria met