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Impact of IVUS-guided treatment on revascularization outcomes in complex coronary lesions

IMPact on Revascularization Outcomes of intraVascular Ultrasound Guided Treatment of Complex Lesions and Economic Impact (IMPROVE)

NA · Medstar Health Research Institute · NCT04221815

This study is testing if using ultrasound to guide heart stent placement helps people with complicated heart issues have better outcomes than the traditional method.

Quick facts

PhaseNA
Study typeInterventional
Enrollment3100 (estimated)
Ages18 Years and up
SexAll
SponsorMedstar Health Research Institute (other)
Locations61 sites (Tucson, Arizona and 60 other locations)
Trial IDNCT04221815 on ClinicalTrials.gov

What this trial studies

This clinical investigation compares the effectiveness of intravascular ultrasound (IVUS)-guided coronary stent implantation to traditional angiography-guided stent implantation in patients with high-risk or complex coronary lesions. The study will enroll approximately 2,500-3,100 participants across 120 centers in the US, Canada, and Europe, with a follow-up period of two years. The goal is to determine if IVUS guidance can reduce adverse clinical events while being cost-effective. Participants will be randomized in a 1:1 ratio to receive either treatment approach.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with high-risk or complex coronary lesions requiring stent implantation.

Not a fit: Patients with acute ST elevation myocardial infarction (STEMI) or those requiring staged revascularization procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved outcomes and reduced complications for patients undergoing PCI for complex coronary lesions.

How similar studies have performed: Previous studies have shown that IVUS guidance can improve outcomes in PCI, suggesting that this approach may be beneficial for complex lesions as well.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Age ≥ 18 years at screening
* PCI with stent implantation involving a high risk or complex lesion defined as involving at least one of the following characteristics:
* Chronic total occlusion
* In-stent restenosis
* Severe coronary artery calcification
* Long lesion (≥ 28 mm in length)
* Bifurcation lesion (Any Medina class that involves main branch disease with a side branch ≥2.0 mm)
* 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

Exclusion Criteria:

* Subjects with acute ST elevation myocardial infarction (STEMI), or cardiogenic shock
* Use of fibrinolytic therapy within 24 hours of PCI
* Planned revascularization of a target vessel as a staged procedure
* Stent thrombosis
* Use of optical coherence tomography (OCT) during the index procedure

Where this trial is running

Tucson, Arizona and 60 other locations

+11 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Atherosclerosis

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.