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

Completed

• Conditions: Coronary Artery Disease
• Interventions: Procedure: FFR and IVUS guided PCI

• Registration Number: NCT05621421
• Lead Sponsor: Vilnius University Hospital Santaros Klinikos

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-01
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Status Verified: 2022-11
• Study First Submitted: 2022-11-03
• Study First Submitted QC: 2022-11-09
• Last Update Submitted: 2022-11-09
• Study First Posted: 2022-11-18
• Last Update Posted: 2022-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with long coronary artery lesions	FFR and IVUS guided PCI	Consecutive patients with functionally significant (FFR ≤ 0.8) long lesion requiring a stent length of ≥ 30mm to undergo FFR and IVUS guided PCI.

Primary Outcome Measures

Name	Time	Method
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 result	1 day	Post PCI FFR value ≥ 0.9
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 Outcome Measures

Name	Time	Method
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))

Trial Locations

Locations (1)

Vilnius University Hospital Santaros Klinikos; 🇱🇹 Vilnius, Lithuania