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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05732324

Enrollment

154

Registered

2023-02-17

Start date

2012-09-01

Completion date

2022-03-31

Last updated

2023-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Myocardial Infarction, Myocardial Ischemia

Brief summary

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.

Interventions

PROCEDUREIVUS guided PCI optimization

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

PROCEDUREFFR guided PCI optimization

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

DIAGNOSTIC_TESTFFR 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.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
The rate of optimal functional PCI result	One year	Post PCI FFR value \< 0.9
The rate of poor functional PCI result	One year	Post PCI FFR value ≤ 0.8
The rate of optimal anatomical PCI result	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

Measure	Time frame	Description
The rate of target vessel failure (TVF)	One year	Composite endpoint (target vessel related death (TV-death), target vessel related myocardial infarction (TV-MI), any target vessel revascularization (TV-R))

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026