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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05732324
• Other study ID #: 19C1252
• Status: Completed
• Start date: September 1, 2012
• Est. completion date: March 31, 2022

Study information

• Verified date: February 2023
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• 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
• Infarction
• Ischemia
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Procedure:
• IVUS guided PCI optimization
PCI to long lesion will be optimized according to the IVUS.
• FFR guided PCI optimization
PCI to long lesion will be optimized according to the FFR.

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Vilnius University Hospital Santaros Klinikos	Vilnius University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of optimal functional PCI result	Post PCI FFR value < 0.9	One year
Primary	The rate of poor functional PCI result	Post PCI FFR value = 0.8	One year
Primary	The rate of optimal anatomical PCI 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
Secondary	The rate of target vessel failure (TVF)	Composite endpoint (target vessel related death (TV-death), target vessel related myocardial infarction (TV-MI), any target vessel revascularization (TV-R))	One year