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

February 19, 2023 updated by: Povilas Budrys, Vilnius University Hospital Santaros Klinikos
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

154

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IVUS PCI optimization group

PCI will be optimized according to the IVUS. IVUS will be performed before PCI and will be used to select PCI strategy.

Operators will try to reach an optimal anatomical PCI result as assessed by IVUS aiming for the following criteria:

  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.

After stent optimization an IVUS run will be performed. The IVUS run will be considered as final when further anatomical optimization will not be thought to be possible.
Procedure: IVUS guided PCI optimization
PCI to long lesion will be optimized according to the IVUS.
Diagnostic test: FFR measurement
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.
Historical FFR PCI optimization group
The goal will be to achieve the optimal functional result, defined as an FFR post PCI ≥ 0.95. Further stented segment post-dilatation will be mandatory if FFR post PCI < 0.95. In case of a clear evidence of significant atheroma proximal or distal to the stented segment, the operators will be encouraged to optimize the functional result further by implanting additional stents.
Diagnostic test: FFR measurement
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.
Procedure: FFR guided PCI optimization
PCI to long lesion will be optimized according to the FFR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of optimal functional PCI result
Time Frame: One year
Post PCI FFR value < 0.9
One year
The rate of poor functional PCI result
Time Frame: One year
Post PCI FFR value ≤ 0.8
One year
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.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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))
One year

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)

September 1, 2012

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

March 31, 2022

Study Registration Dates

First Submitted

February 7, 2023

First Submitted That Met QC Criteria

February 7, 2023

First Posted (Actual)

February 17, 2023

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 19, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19C1252

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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