IVUS-Guided PCI for Atherosclerosis

(IMPROVE Trial)

Recruiting in Palo Alto (17 mi)

+59 other locations

Overseen by Ronald Waksman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Medstar Health Research Institute

Disqualifiers: STEMI, Cardiogenic shock, others

Trial Summary

What is the purpose of this trial?

Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) has been shown in clinical trials, registries, and meta-analyses to reduce recurrent events after PCI. This is accomplished by improving the angiographic result with lesion and vessel assessment to guide stent selection and implantation and intravascular imaging following stent implantation to ensure an adequate treatment endpoint has been achieved. Despite extensive literature supporting the use of IVUS in PCI, utilization remains low in the United States. An increasing number of high-risk or complex lesions are being treated with PCI and we hypothesize that the impact of IVUS in these complex lesions will be of increased importance in reducing clinical adverse events while remaining cost effective.

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.

Is IVUS-guided PCI generally safe for humans?

There is some safety information about IVUS-guided PCI, particularly regarding the risk of the IVUS catheter getting stuck within stents during procedures. This situation has been studied, and methods for safely retrieving the catheter have been developed, suggesting that while there are risks, they are manageable.

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How is the IVUS-Guided PCI treatment for atherosclerosis unique?

The IVUS-Guided PCI treatment is unique because it uses an intravascular ultrasound (IVUS) catheter to guide the placement of a drug-eluting stent, which helps doctors see inside the blood vessels and ensure the stent is placed correctly. This approach can lead to better outcomes by allowing for precise stent placement and optimal expansion, which is not possible with traditional methods that rely solely on angiographic guidance.

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Eligibility Criteria

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 have had a severe heart attack or experienced heart failure.

Trial Timeline

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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Good Samaritan University Hospital West Islip, NY

Rush University Medial Center Chicago, IL

Brigham and Women's Hospital Boston, MA

Central Arkansas Veterans Healthcare System Little Rock, AR

More Trial Locations

Who Is Running the Clinical Trial?

Medstar Health Research Institute Lead Sponsor

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of edge vascular response after sirolimus- and paclitaxel-eluting stent implantation. [2016] To compare the edges vascular response, we analyzed the intravascular ultrasound (IVUS) parameters after implantation of the sirolimus-eluting stent (SES) or the paclitaxel-eluting stent (PES).

2. Netherlands pubmed.ncbi.nlm.nih.gov

Incidence, retrieval methods, and outcomes of intravascular ultrasound catheter stuck within an implanted stent: Systematic literature review. [2020] There have been no reviews regarding intravascular ultrasound (IVUS) catheter entrapment during percutaneous coronary intervention (PCI). This study investigated the incidence, retrieval methods, and outcomes of IVUS catheter stuck within implanted stents.

3. United States pubmed.ncbi.nlm.nih.gov

Intravascular ultrasound in the drug-eluting stent era. [2022] Intravascular ultrasound (IVUS) has become an indispensable part of all drug-eluting stent (DES) studies; findings must be put into context with the IVUS findings in bare metal stents. Unfortunately, there is not yet a complete picture of either the Cypher (Cordis, Miami, Florida) or the Taxus (Boston Scientific, Maple Grove, Minnesota) stent (the two U.S. Food and Drug Administration-approved devices). Intimal hyperplasia volume in DES is reduced to

4. France 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. [2016] The purpose of this study was to investigate the vascular response of the everolimus-eluting stent (EES) compared with the paclitaxel-eluting stent (PES) using serial intravascular ultrasound (IVUS).

5. United States pubmed.ncbi.nlm.nih.gov

Predictors of recurrence based on intravascular ultrasound findings after Eluvia placement in symptomatic peripheral arterial disease: A retrospective study. [2023] Polymer-coated drug-eluting stents (Eluvia) have shown favorable clinical outcomes in real-world registries. There are no reports on recurrent predictors after Eluvia placement based on intravascular ultrasound (IVUS) findings.

6. France 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. [2016] To compare the intravascular ultrasonography (IVUS) findings between saphenous vein grafts (SVG) treated with paclitaxel-eluting stents (PES) vs. bare metal stents (BMS) in the Stenting Of Saphenous Vein Grafts (SOS) trial.

7. United States pubmed.ncbi.nlm.nih.gov

Intravascular ultrasound images as an essential tool to assist left main operating strategy. [2016] Intravascular ultrasound (IVUS) remains the only tool to understand, plan and evaluate complex lesions in percutaneous coronary intervention (PCI). Despite the evidence for left main intervention, 1 it is routinely used mainly to validate the final results in terms of optimal expansion of the stent. In this case report, we wish to highlight the role of IVUS guidance in the decision-making process throughout the PCI procedure.

8. Netherlands pubmed.ncbi.nlm.nih.gov

Primary and mid-term outcome of sirolimus-eluting stent implantation with angiographic guidance alone. [2013] Usefulness and efficacy of intravascular ultrasound (IVUS) for the implantation of sirolimus-eluting stent (SES) is controversial. We investigated the primary and mid-term results of SES deployment with angiographic guidance comparing with IVUS guidance, retrospectively.