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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05621421
• Other study ID #: 19-C-1252
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: November 2022
• Source: Vilnius University Hospital Santaros Klinikos
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Procedure:
• FFR and IVUS guided PCI
PCI to the long lesion guided with FFR and IVUS

Locations

Country	Name	City	State
Lithuania	Vilnius University Hospital Santaros Klinikos	Vilnius

Sponsors (2)

Lead Sponsor	Collaborator
Vilnius University Hospital Santaros Klinikos	Vilnius University

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients with optimal physiology result	Post PCI FFR value = 0.9	1 day
Primary	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.	1 day
Primary	The proportion of patients with optimal physiology and anatomy result	Post PCI FFR value = 0.9 and all four IVUS criteria met	1 day
Secondary	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))	12 months post PCI follow up