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Active, Not Recruiting

NCT Number: NCT04221815

IMPact on Revascularization Outcomes of IVUS Guided Treatment of Complex Lesions and Economic Impact

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nicosia General Hospital, Nicosia, Cyprus

Loading trial locations.

About this study

This is a prospective, single-blind clinical investigation randomizing subjects to IVUS-guided coronary stent implantation vs. angiography-guided coronary stent implantation in a 1:1 ratio.

The clinical investigation will be conducted at approximately 120 centers in the US, Canada, and Europe. Approximately 2,500-3,100 randomized subjects and up to 3 roll-in subjects per site will be enrolled in this study. Subjects participating in this clinical investigation will be followed for 2 years. The expected duration of enrollment is approximately 2.5 years. The total duration of the clinical investigation is expected to be approximately 4.5 years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eagle Eye Platinum digital IVUS catheter with optional SyncVision

Device

IVUS catheter

Resolute Onyx Drug Eluting Stent

Device

Stent

Onyx Frontier Drug Eluting Stent

Device

Stent

Onyx TruStar Drug Eluting Stent

Device

Stent

Onyx TruCor Drug Eluting Stent

Device

Stent

Primary outcomes

  1. IVUS core lab measures final PCI Minimum Stent Area

    Time frame: Intra-procedural

    The imaging primary endpoint is the final post-PCI minimum stent area (MSA) assessed by IVUS in each randomized arm, measured at an independent IVUS core laboratory blinded to treatment assignment. The MSA is an appropriate co-primary imaging endpoint as it is the most consistent and strongest parameter to predict clinical outcomes.11-14 In the present study, after 2,000 subjects are enrolled with the procedure completed, the primary endpoint of MSA will be tested to compare the IVUS-guided and angiography-guided arms. If significantly larger MSA in the IVUS-guided arm is demonstrated, the trial will continue enrolling subjects.

  2. 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.

    Time frame: 12 months

    The clinical primary endpoint is target vessel failure (TVF) outcomes at 12 months defined as the composite of cardiac death, target vessel related- myocardial infarction (MI), and target vessel revascularization.

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Registry information

Official study title

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

Acronym: IMPROVE

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Jan 9, 2020
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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