IVUS-Guided PCI for Atherosclerosis

(IMPROVE Trial)

Not currently recruiting at 66 trial locations

Overseen By Shreejana Pokharel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medstar Health Research Institute

Disqualifiers: STEMI, Cardiogenic shock, others

Compensation: Varies

Number of Visits: Unknown

Duration: Intra-procedural

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if intravascular ultrasound (IVUS), a special imaging technique, can better guide doctors in placing stents—tiny tubes that help keep arteries open—during heart procedures. The goal is to assess whether this method can reduce complications for individuals with challenging artery blockages, such as chronic total blockages or severe calcifications. Participants should have stable or unstable angina (chest pain) or non-ST elevation myocardial infarction (a type of heart attack) and be undergoing a procedure to address complex artery blockages. The trial compares two groups: one using traditional imaging and another using IVUS to guide the procedure with the Eagle Eye Platinum digital IVUS catheter. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could enhance heart procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that IVUS-guided PCI is safe for treating atherosclerosis?

Studies have shown that the Eagle Eye Platinum digital IVUS catheter provides detailed images to help doctors examine blood vessels. However, sufficient data on its safety and effectiveness for identifying specific blood vessel problems is lacking. While it enhances visibility, its diagnostic efficacy for certain issues remains uncertain.

In contrast, the Resolute Onyx drug-eluting stent has undergone thorough research. Studies show it is safe and effective, particularly for patients with complex artery problems. Reports indicate a low rate of complications, making it a reliable option for many patients requiring stents.

In this clinical trial, both the imaging tool and the stent are used together to potentially improve treatment for atherosclerosis. While the stent has clear safety data, the imaging tool primarily aims to enhance treatment precision, despite its unconfirmed safety for certain diagnostic uses. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores whether using IVUS (Intravascular Ultrasound) guidance during PCI (Percutaneous Coronary Intervention) can improve outcomes for patients with atherosclerosis. Unlike the traditional angiography-guided approach, which relies on X-ray images to place stents, IVUS provides detailed images from inside the artery. This allows for more precise stent sizing and placement, potentially leading to better artery expansion and reduced complications. By comparing these two methods, researchers hope to determine if IVUS guidance can make heart procedures safer and more effective.

What evidence suggests that this trial's treatments could be effective for atherosclerosis?

This trial will compare two approaches for percutaneous coronary intervention (PCI) in patients with atherosclerosis. One group will receive IVUS-guided PCI, using the Eagle Eye Platinum IVUS catheter for stent sizing and optimization. Studies have shown that intravascular ultrasound (IVUS) during procedures to open blocked heart arteries can lead to better outcomes. IVUS allows doctors to see inside blood vessels, enabling more accurate stent placement and reducing post-procedure complications. The Eagle Eye Platinum IVUS catheter provides quick and easy imaging, making it a valuable tool in these procedures.

Another group in this trial will receive angiographic-guided PCI, the standard practice. Research indicates that the Resolute Onyx stent, when guided by IVUS, shows positive results in treating blocked heart arteries by reducing negative heart events. Both tools aim to improve the success of heart procedures, especially in complex cases. ^{1 6 7 8 9}

Who Is on the Research Team?

Ron Waksman, MD

Principal Investigator

MedStar Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

My heart procedure was guided by imaging or ultrasound.

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

Exclusion Criteria

I have received clot-dissolving medication within 24 hours before a heart procedure.

You have a stent thrombosis.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either IVUS-guided or angiography-guided PCI, with stent implantation and optimization

Intra-procedural

Follow-up

Participants are monitored for target vessel failure outcomes, including cardiac death, myocardial infarction, and revascularization

12 months

Long-term follow-up

Participants are followed for additional safety and effectiveness outcomes

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Eagle Eye Platinum digital IVUS catheter with optional SyncVision
• Resolute Onyx Drug Eluting Stent

Trial Overview 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.

How Is the Trial Designed?

Group I: IVUS guided PCI Active Control 5 Interventions

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

Group II: Angiographic-guided PCI Placebo Group 4 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

Eagle Eye Platinum digital IVUS catheter with optional SyncVision is already approved in United States, European Union for the following indications:

Approved in United States as Eagle Eye Platinum digital IVUS catheter for:

• Percutaneous coronary intervention (PCI) for complex coronary artery lesions

Approved in European Union as Eagle Eye Platinum digital IVUS catheter for:

• Percutaneous coronary intervention (PCI) for complex coronary artery lesions

Who Is Running the Clinical Trial?

Medstar Health Research Institute

Lead Sponsor

Trials

202

Recruited

187,000+

Published Research Related to This Trial

Intravascular ultrasound (IVUS) is a crucial tool for understanding and evaluating complex coronary lesions during percutaneous coronary intervention (PCI), beyond just validating stent expansion.

This case report emphasizes the importance of using IVUS guidance throughout the entire PCI procedure to enhance decision-making and improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravascular ultrasound images as an essential tool to assist left main operating strategy. Attisano, T., Baldi, C., Giudice, P.[2016]

In a study involving 480 lesions in 459 patients, the use of intravascular ultrasound (IVUS) for deploying sirolimus-eluting stents (SES) did not show significant differences in late luminal loss, in-stent restenosis, or target lesion revascularization compared to angiographic guidance alone.

While SES implantation without IVUS was found to be safe and effective, IVUS may be beneficial for complex lesions to help determine stent size and potentially reduce complications, as evidenced by a case of difficult target-vessel revascularization due to mal-apposition in the non-IVUS group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary and mid-term outcome of sirolimus-eluting stent implantation with angiographic guidance alone. Fujimoto, H., Tao, S., Dohi, T., et al.[2013]

In a study of 202 angina patients, the paclitaxel-eluting stent (PES) showed a higher edge restenosis rate compared to the sirolimus-eluting stent (SES), indicating potential safety concerns with PES.

While both stents exhibited negative remodeling, the PES group experienced significant plaque progression and a reduction in lumen area at the edge segments, whereas the SES group showed plaque regression and an increase in lumen area, suggesting that SES may be more effective in maintaining vessel patency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of edge vascular response after sirolimus- and paclitaxel-eluting stent implantation. Kang, WC., Park, YM., Shin, KC., et al.[2016]

The study found that the everolimus-eluting stent (EES) resulted in significantly less neointimal hyperplasia compared to the paclitaxel-eluting stent (PES), with a smaller neointimal volume index and percentage obstruction at eight months.

EES did not show an increase in vessel volume over the follow-up period, while PES exhibited a significant increase in vessel volume, indicating a potential advantage of EES in maintaining vascular health post-stenting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of vascular response to the everolimus-eluting stent versus the paclitaxel-eluting stent: intravascular ultrasound results from the SPIRIT III trial. Yamasaki, M., Tsujino, I., Lima-Filho, MO., et al.[2016]

Intravascular ultrasound (IVUS) is crucial for evaluating drug-eluting stents (DES) and comparing their performance to bare metal stents, highlighting the importance of stent expansion in preventing complications.

While drug-eluting stents significantly reduce intimal hyperplasia volume to less than 15% of stent volume, issues like stent underexpansion remain a common cause of failures, emphasizing the need for IVUS to ensure proper stent placement, especially in patients with risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravascular ultrasound in the drug-eluting stent era. Mintz, GS., Weissman, NJ.[2022]

In a study involving 38 patients from the SOS trial, those treated with paclitaxel-eluting stents (PES) showed significantly less neointimal hyperplasia (NIH) volume at 12 months compared to those with bare metal stents (BMS), indicating better long-term outcomes for PES.

The volume of NIH was 3.4 mm³ for PES versus 21.9 mm³ for BMS, suggesting that PES may reduce the risk of complications associated with grafts, which could explain the improved clinical results seen with PES in saphenous vein grafts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel-eluting stents reduce neointimal hyperplasia compared to bare metal stents in saphenous vein grafts: intravascular ultrasonography analysis of the SOS (Stenting of Saphenous Vein Grafts) trial. Jeroudi, OM., Abdel-Karim, AR., Michael, TT., et al.[2016]

In a study of 794 patients undergoing percutaneous coronary intervention (PCI), 1.4% experienced entrapment of an intravascular ultrasound (IVUS) catheter within implanted stents, particularly in cases with tortuous or severely calcified lesions.

Successful retrieval of the IVUS catheter was achieved in all cases using various techniques, highlighting the importance of recognizing specific risk factors such as tortuous lesions and small stent diameters (≤2.5mm) to prevent entrapment during PCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence, retrieval methods, and outcomes of intravascular ultrasound catheter stuck within an implanted stent: Systematic literature review. Hiraya, D., Sato, A., Hoshi, T., et al.[2020]

In a study of 65 patients who received Eluvia drug-eluting stents, 13% experienced target lesion recurrence within 12 months, highlighting the need for careful monitoring after stent placement.

Key predictors of recurrence included clinical frailty, stent edge area, plaque burden, age, sex, and various IVUS measurements, suggesting that these factors should be considered in post-procedure assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of recurrence based on intravascular ultrasound findings after Eluvia placement in symptomatic peripheral arterial disease: A retrospective study. Yamada, T., Tokuda, T., Yoshioka, N., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04221815

IMPact on Revascularization Outcomes of IVUS Guided ... This is a prospective, single-blind clinical investigation randomizing subjects to IVUS-guided coronary stent implantation vs. angiography-guided coronary stent ...

2. usa.philips.com usa.philips.com/healthcare/product/HC85900P/eagle-eye-platinum-digital-ivus-catheter

Eagle Eye Platinum Digital IVUS catheter The plug-and-play simplicity and digital, solid state design of the Eagle Eye Platinum digital IVUS catheter provides a fast, easy approach for IVUS imaging.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8422435/

Clinical Outcomes and Prevalence of Intravascular ... We aimed to determine the prevalence of IVUS use and clinical outcomes of IVUS-guided percutaneous treatment of coronary arteries lesions in a South Asian ...

4. 55933-bcmed.s3.amazonaws.com 55933-bcmed.s3.amazonaws.com/bcp/files/flexpaper/pdf/phi_d041406-01-eagle-eye-platinum-data-sheet.pdf

simplicity Comparison of in-hospital mortality, length of hospitalization, costs, and vascular complications of percutaneous coronary interventions guided by ultrasound ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5808501/

Impact of Intravascular Ultrasound in Clinical Practice - PMC IVUS is safe, cost efficient and effective in guiding clinical decisions and cardiovascular interventions and improves outcomes when used during coronary ...

6. philips.sa philips.sa/en/healthcare/product/HC85900P/eagle-eye-platinum-digital-ivus-catheter

Eagle Eye Platinum Digital IVUS catheter IVUS imaging helps physicians assess disease markers, including plaque burden percentage, lesion location and morphology, calcium volume, and the presence of ...

7. news-medical.net news-medical.net/Eagle-Eye-Platinum-ST-Digital-IVUS-Catheter-from-Philips-Healthcare

Eagle Eye Platinum ST Digital IVUS Catheter from Philips ... The Eagle Eye Platinum ST digital IVUS catheter offers a 2.5 mm tip-to-imaging distance designed to assess more of the vessel than standard catheters.

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf21/K210655.pdf

May 25, 2022 Innovative Health, LLC. Christina Fleming VP ... The Reprocessed Eagle Eye Platinum RX Digital IVUS Catheters are designed for use in the evaluation of vascular morphology in blood vessels of ...

9. ptca.org ptca.org/news/2011/0304_VOLCANO_IVUS.html

Volcano Announces the Introduction of the Eagle Eye® ... Like Eagle Eye® Gold, the Eagle Eye® Platinum catheter offers fast, plug-and-play functionality as well as grayscale IVUS, VH® IVUS, and ...