Comparison of Percutaneous Coronary Intervention Optimization With Fractional Flow Reserve Versus Intravascular Ultrasound in the Treatment of Long Coronary Artery Lesions
1 other identifier
observational
154
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2012
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedFirst Submitted
Initial submission to the registry
February 7, 2023
CompletedFirst Posted
Study publicly available on registry
February 17, 2023
CompletedFebruary 22, 2023
February 1, 2023
9.6 years
February 7, 2023
February 19, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
The rate of optimal functional PCI result
Post PCI FFR value \< 0.9
One year
The rate of poor functional PCI result
Post PCI FFR value ≤ 0.8
One year
The rate of optimal anatomical PCI result
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.
1 day
Secondary Outcomes (1)
The rate of target vessel failure (TVF)
One year
Study Arms (2)
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.
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.
Interventions
PCI to long lesion will be optimized according to the IVUS.
PCI to long lesion will be optimized according to the FFR.
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.
Eligibility Criteria
Patients with functionally significant long coronary artery lesions amenable to percutaenous coronary intervention.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vilnius University Hospital Santaros Klinikoslead
- Vilnius Universitycollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Giedrius Davidavicius, PhD, prof
Vilnius University Hospital Santaros Klinikos
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 7, 2023
First Posted
February 17, 2023
Study Start
September 1, 2012
Primary Completion
March 31, 2022
Study Completion
March 31, 2022
Last Updated
February 22, 2023
Record last verified: 2023-02