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OpenTrials
Completed

NCT Number: NCT05621421

The Implementation of Intravascular Ultrasound and Fractional Flow Reserve in the Percutaneous Treatment of Very Long Coronary Artery Lesions

A single center, prospective, observational study to investigate the impact of intravascular ultrasound (IVUS) on the functional percutaneous coronary intervention (PCI) result (assessed with fractional flow reserve (FFR)) and one-year target vessel failure (TVF) rate after percutaneous treatment of long coronary artery lesions

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vilnius University Hospital Santaros Klinikos

Vilnius, 08410, Lithuania

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chronic coronary syndrome (stable angina; staged PCI to other lesions after acute myocardial infarction with ST segment elevation);
  • Acute coronary syndrome without ST segment elevation (unstable angina or myocardial infarction without ST segment elevation);
  • Functionally significant (FFR ≤ 0.8) lesion requiring a stent length of ≥ 30 mm and amenable for percutaneous coronary intervention.

Exclusion criteria

  • Patient's age ≤ 18 years;
  • Acute myocardial infarction with ST segment elevation;
  • Treatment with dual antiplatelet therapy contraindicated;
  • Survival expectancy ≤ 1 year;
  • Known allergy to sirolimus, everolimus or zotarolimus.

Treatment and study plan

FFR and IVUS guided PCI

Procedure

PCI to the long lesion guided with FFR and IVUS

Primary outcomes

  1. The proportion of patients with optimal physiology result

    Time frame: 1 day

    Post PCI FFR value ≥ 0.9

  2. The proportion of patients with optimal anatomy result

    Time frame: 1 day

    If all the four following IVUS criteria met: (1) good stent apposition; (2) good stent expansion (minimal stent area (MSA) >90% of distal reference lumen area and/or MSA ≥5.5mm2); (3) plaque burden 5mm proximal and distal to the stent <50%); (4) no stent edge dissection.

  3. The proportion of patients with optimal physiology and anatomy result

    Time frame: 1 day

    Post PCI FFR value ≥ 0.9 and all four IVUS criteria met

Secondary outcomes

  1. The rate of target vessel failure (TVF)

    Time frame: 12 months post PCI follow up

    Composite endpoint (target vessel related death (TV-death), target vessel related myocardial infarction (TV-MI), ischemia driven target vessel revascularization (TV-R))

Sponsors and collaborators

Lead sponsor

Vilnius University Hospital Santaros Klinikos

Other

Collaborators

  • Vilnius University

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 18, 2022
Registry last updated
Nov 18, 2022

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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