The Implementation of Intravascular Ultrasound and Fractional Flow Reserve in the Percutaneous Treatment of Very Long Coronary Artery Lesions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Vilnius University Hospital Santaros Klinikos
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- The proportion of patients with optimal anatomy result
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
A single center, prospective, observational study to investigate the impact of intravascular ultrasound (IVUS) on the functional percutaneous coronary intervention (PCI) result (assessed with fractional flow reserve (FFR)) and one-year target vessel failure (TVF) rate after percutaneous treatment of long coronary artery lesions
Investigators
Povilas Budrys
Principal investigator
Vilnius University Hospital Santaros Klinikos
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.
Outcomes
Primary Outcomes
The proportion of patients with optimal anatomy result
Time Frame: 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.
The proportion of patients with optimal physiology result
Time Frame: 1 day
Post PCI FFR value ≥ 0.9
The proportion of patients with optimal physiology and anatomy result
Time Frame: 1 day
Post PCI FFR value ≥ 0.9 and all four IVUS criteria met
Secondary Outcomes
- The rate of target vessel failure (TVF)(12 months post PCI follow up)