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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05621421

Enrollment

Registered

2022-11-18

Start date

2019-07-01

Completion date

2021-03-31

Last updated

2022-11-18

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

Conditions

Coronary Artery Disease

Brief 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

Interventions

PROCEDUREFFR and IVUS guided PCI

PCI to the long lesion guided with FFR and IVUS

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 proportion of patients with optimal physiology result	1 day	Post PCI FFR value ≥ 0.9
The proportion of patients with optimal anatomy 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.
The proportion of patients with optimal physiology and anatomy result	1 day	Post PCI FFR value ≥ 0.9 and all four IVUS criteria met

Secondary

Measure	Time frame	Description
The rate of target vessel failure (TVF)	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))

Countries

Lithuania

Outcome results

None listed

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