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

Vilnius University Hospital Santaros Klinikos

Status: Completed

Conditions: Coronary Artery Disease; Myocardial Ischemia; Myocardial Infarction

Treatments: Diagnostic Test: FFR measurement; Procedure: IVUS guided PCI optimization; Procedure: FFR guided PCI optimization

Study type: Observational

Funder types: Other

Identifiers

NCT05732324

19C1252

Details and patient eligibility

About

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.

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

154 participants in 2 patient groups

IVUS PCI optimization group

Description:

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.

Treatment:

Diagnostic Test: FFR measurement

Procedure: IVUS guided PCI optimization

Historical FFR PCI optimization group

Description:

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.

Treatment:

Diagnostic Test: FFR measurement

Procedure: FFR guided PCI optimization