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

Completed

• Conditions: Coronary Artery Disease; Myocardial Ischemia; Myocardial Infarction

• Registration Number: NCT05732324
• Lead Sponsor: Vilnius University Hospital Santaros Klinikos

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-01
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2023-02
• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-07
• Study First Posted: 2023-02-17
• Last Update Submitted: 2023-02-19
• Last Update Posted: 2023-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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

Primary Outcome Measures

Name	Time	Method
The rate of optimal functional PCI result	One year	Post PCI FFR value \< 0.9
The rate of poor functional PCI result	One year	Post PCI FFR value ≤ 0.8
The rate of optimal anatomical PCI 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.

Secondary Outcome Measures

Name	Time	Method
The rate of target vessel failure (TVF)	One year	Composite endpoint (target vessel related death (TV-death), target vessel related myocardial infarction (TV-MI), any target vessel revascularization (TV-R))