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

NCT ID: NCT05732324

Last Updated: 2023-02-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 154 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-09-01
• Study Completion Date: 2022-03-31

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.

Conditions

Coronary Artery Disease; Myocardial Ischemia; Myocardial Infarction

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

IVUS PCI optimization group

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 guided PCI optimization

Intervention Type: PROCEDURE

PCI to long lesion will be optimized according to the IVUS.

FFR measurement

Intervention Type: DIAGNOSTIC_TEST

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.

Historical FFR PCI optimization group

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.

FFR guided PCI optimization

Intervention Type: PROCEDURE

PCI to long lesion will be optimized according to the FFR.

FFR measurement

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

IVUS guided PCI optimization

PCI to long lesion will be optimized according to the IVUS.

Intervention Type: PROCEDURE

FFR guided PCI optimization

PCI to long lesion will be optimized according to the FFR.

Intervention Type: PROCEDURE

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vilnius University

OTHER

Sponsor Role: collaborator

Vilnius University Hospital Santaros Klinikos

OTHER

Sponsor Role: lead

Responsible Party

Povilas Budrys

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giedrius Davidavicius, PhD, prof

Role: STUDY_CHAIR

Vilnius University Hospital Santaros Klinikos

Other Identifiers

19C1252

Identifier Type: -

Identifier Source: org_study_id