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OpenTrials
Completed

NCT Number: NCT05732324

Comparison of Percutaneous Coronary Intervention Optimization With Fractional Flow Reserve Versus Intravascular Ultrasound in the Treatment of Long Coronary Artery Lesions

A single center, prospective, observational study to compare fractional flow reserve (FFR) and intravascular ultrasound (IVUS) percutaneous coronary intervention (PCI) optimization strategies on the functional PCI result (assessed with FFR) immediately post PCI and at 9-12 months after the 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 Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

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

IVUS guided PCI optimization

Procedure

PCI to long lesion will be optimized according to the IVUS.

FFR guided PCI optimization

Procedure

PCI to long lesion will be optimized according to the FFR.

FFR measurement

Diagnostic Test

Fractional flow reserve protocol will be applied for both FFR-guided and IVUS-guided PCI groups. FFR will be measured according to the standard practice using intravenous adenosine. FFR will be recorded before PCI at the distal third of the coronary artery and after PCI at the same location. In FFR optimization group more than one post PCI FFR measurements could be acquired if the operators performed additional optimization. In IVUS optimization group only one post PCI FFR measurement will be recorded after which the procedure will be considered to be finished, and no further interventions will be undertaken. The same FFR measurements will be performed at 9-12 months follow-up.

Primary outcomes

  1. The rate of optimal functional PCI result

    Time frame: One year

    Post PCI FFR value < 0.9

  2. The rate of poor functional PCI result

    Time frame: One year

    Post PCI FFR value ≤ 0.8

  3. The rate of optimal anatomical PCI 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.

Secondary outcomes

  1. The rate of target vessel failure (TVF)

    Time frame: One year

    Composite endpoint (target vessel related death (TV-death), target vessel related myocardial infarction (TV-MI), any 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
2012
Primary completion
2022
Study completion
2022
First posted
Feb 17, 2023
Registry last updated
Feb 22, 2023

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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