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

November 9, 2022 updated by: Povilas Budrys, Vilnius University Hospital Santaros Klinikos
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lithuania
      • Vilnius, Lithuania, 08410
        • Vilnius University Hospital Santaros Klinikos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
PCI to the long lesion guided with FFR and IVUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of patients with optimal physiology result
Time Frame: 1 day
Post PCI FFR value ≥ 0.9
1 day
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.
1 day
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
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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))
12 months post PCI follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vilnius University Hospital Santaros Klinikos

Collaborators

Vilnius University

Investigators

  • Study Chair: Giedrius Davidavicius, PhD, prof, Vilnius University Hospital Santaros Klinikos

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

March 31, 2021

Study Registration Dates

First Submitted

November 3, 2022

First Submitted That Met QC Criteria

November 9, 2022

First Posted (Actual)

November 18, 2022

Study Record Updates

Last Update Posted (Actual)

November 18, 2022

Last Update Submitted That Met QC Criteria

November 9, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-C-1252

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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