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IVUS-Guided PCI for Atherosclerosis (IMPROVE Trial)

N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

IMPROVE Trial 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.Check my eligibility
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.See study design
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.

IMPROVE Trial 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.

IMPROVE Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.

IMPROVE Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: IVUS guided PCIActive Control2 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 Group1 Intervention
Patients will receive angiography guided PCI and angiographic optimization per local standard practice, as well as a post-PCI IVUS blinded to the investigator

Find a Location

Who is running the clinical trial?

Medstar Health Research InstituteLead Sponsor
189 Previous Clinical Trials
112,561 Total Patients Enrolled
3 Trials studying Atherosclerosis
3,017 Patients Enrolled for Atherosclerosis

Media Library

Eagle Eye Platinum digital IVUS catheter with optional SyncVision (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04221815 — N/A
Atherosclerosis Research Study Groups: Angiographic-guided PCI, IVUS guided PCI
Atherosclerosis Clinical Trial 2023: Eagle Eye Platinum digital IVUS catheter with optional SyncVision Highlights & Side Effects. Trial Name: NCT04221815 — N/A
Eagle Eye Platinum digital IVUS catheter with optional SyncVision (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04221815 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of enrollment for this empirical research?

"Correct. Perusing clinicaltrials.gov, it is evident that this medical experiment commenced on October 14th 2020 and has been actively seeking participants since then. In total, 3100 individuals must be recruited from 30 trial sites."

Answered by AI

How many areas within the state are currently collaborating on this research endeavor?

"Patients can receive this medication at St. Luke's Hospital of Duluth in Duluth, Minnesota, AdventHealth Sebring in Sebring, Florida and Texas Tech University Health Sciences Center in El Paso, Texas; as well as 30 other medical centres throughout the country."

Answered by AI

Is it currently feasible to join the clinical trial?

"Affirmative. Clinicaltrials.gov hosts the information that indicates this trial, which was first announced on October 14th 2020 is currently recruiting participants. In total, 3100 patients are needed across 30 different medical facilities."

Answered by AI
~0 spots leftby Apr 2024