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
• Interventions: Procedure: IVUS guided PCI optimization; Procedure: FFR guided PCI optimization; Diagnostic Test: FFR measurement

• 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

Arm && Interventions

Group	Intervention	Description
IVUS PCI optimization group	IVUS guided PCI optimization	PCI will be optimized according to the IVUS. IVUS will be performed before PCI and will be used to select PCI strategy. Operators will try to reach an optimal anatomical PCI result as assessed by IVUS aiming for the following criteria: 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. After stent optimization an IVUS run will be performed. The IVUS run will be considered as final when further anatomical optimization will not be thought to be possible.
IVUS PCI optimization group	FFR measurement	PCI will be optimized according to the IVUS. IVUS will be performed before PCI and will be used to select PCI strategy. Operators will try to reach an optimal anatomical PCI result as assessed by IVUS aiming for the following criteria: 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. After stent optimization an IVUS run will be performed. The IVUS run will be considered as final when further anatomical optimization will not be thought to be possible.
Historical FFR PCI optimization group	FFR guided PCI optimization	The goal will be to achieve the optimal functional result, defined as an FFR post PCI ≥ 0.95. Further stented segment post-dilatation will be mandatory if FFR post PCI \< 0.95. In case of a clear evidence of significant atheroma proximal or distal to the stented segment, the operators will be encouraged to optimize the functional result further by implanting additional stents.
Historical FFR PCI optimization group	FFR measurement	The goal will be to achieve the optimal functional result, defined as an FFR post PCI ≥ 0.95. Further stented segment post-dilatation will be mandatory if FFR post PCI \< 0.95. In case of a clear evidence of significant atheroma proximal or distal to the stented segment, the operators will be encouraged to optimize the functional result further by implanting additional stents.

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))