IVUS-Guided PCI for Atherosclerosis

(IMPROVE Trial)

Recruiting at 59 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

3100 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

Research Team

Ronald Waksman, MD

Principal Investigator

MedStar Health

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.

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

1. 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]

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

Comparison of edge vascular response after sirolimus- and paclitaxel-eluting stent implantation. [2016]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Incidence, retrieval methods, and outcomes of intravascular ultrasound catheter stuck within an implanted stent: Systematic literature review. [2020]

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

Intravascular ultrasound in the drug-eluting stent era. [2022]

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]

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]

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

Intravascular ultrasound images as an essential tool to assist left main operating strategy. [2016]

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

Primary and mid-term outcome of sirolimus-eluting stent implantation with angiographic guidance alone. [2013]