NCT05732324

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 154 (actual)
• Sponsor: Vilnius University Hospital Santaros Klinikos · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Coronary Artery Disease
• Myocardial Ischemia
• Myocardial Infarction

Interventions

Type	Name	Description
PROCEDURE	IVUS guided PCI optimization	PCI to long lesion will be optimized according to the IVUS.
PROCEDURE	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.

Timeline

• Start date: 2012-09-01
• Primary completion: 2022-03-31
• Completion: 2022-03-31
• First posted: 2023-02-17
• Last updated: 2023-02-22