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CompletedNCT05621421Updated Nov 18, 2022

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

An observational study in Coronary Artery Disease, sponsored by Vilnius University Hospital Santaros Klinikos. Completed at 1 site in Lithuania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-18.

Sponsored by Vilnius University Hospital Santaros Klinikos · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
All
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Study summary

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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Conditions studied

  • Coronary Artery Disease
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In context

Coronary Artery Disease

5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.

This study's enrollment of 80 is below the median of 335 across 1,978 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Vilnius University Hospital Santaros Klinikos is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with functionally significant long coronary artery lesions amenable to percutaenous coronary intervention.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with long coronary artery lesions

    Consecutive patients with functionally significant (FFR ≤ 0.8) long lesion requiring a stent length of ≥ 30mm to undergo FFR and IVUS guided PCI.

    Procedure: FFR and IVUS guided PCI

Interventions

  • ProcedureFFR and IVUS guided PCI

    PCI to the long lesion guided with FFR and IVUS

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What researchers measure

Primary outcomes

  1. The proportion of patients with optimal physiology result

    Post PCI FFR value ≥ 0.9

    Time frame: 1 day

  2. The proportion of patients with optimal anatomy result

    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.

    Time frame: 1 day

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

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

    Time frame: 1 day

Secondary outcomes

  1. The rate of target vessel failure (TVF)

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

    Time frame: 12 months post PCI follow up

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Study locations

1 site
  • Vilnius University Hospital Santaros Klinikos
    Vilnius, 08410, Lithuania
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05621421
Lead sponsor
Vilnius University Hospital Santaros Klinikos
Collaborators
Vilnius University
Responsible party
Povilas Budrys (Principal investigator, Vilnius University Hospital Santaros Klinikos) — Principal investigator
First posted
Nov 18, 2022
Start date
Jul 1, 2019
Primary completion
Mar 31, 2021
Completion
Mar 31, 2021
Last update
Nov 18, 2022

Study contacts

Giedrius Davidavicius, PhD, Prof
study chair · Vilnius University Hospital Santaros Klinikos

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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