Coronary Artery Disease Clinical Trial
— LIPSIASTRATEGYOfficial title:
Comparison of Non-Invasive Vessel Fractional Flow Reserve Calculated From Angiographic Images Versus Fractional Flow Reserve in Patients With Intermediate Coronary Artery Stenoses
This is a prospective, randomized, controlled, multicenter, open-label study designed to assess whether vFFR is non-inferior to FFR in assessment of intermediate coronary stenosis in terms of the occurrence of MACE during 12 months after randomization.
Status | Recruiting |
Enrollment | 1926 |
Est. completion date | November 1, 2026 |
Est. primary completion date | May 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age >18 years - Willing to participate and able to understand, read and sign the informed consent document before the planned procedure - Eligible for coronary angiography and/or PCI - Coronary artery disease in one or more native major epicardial vessels or their branches by coronary angiogram with visually assessed de novo coronary stenosis in which the physiological severity of the lesion is in question (typically 40-80% diameter stenosis). - Stable angina or acute coronary syndrome (non-culprit vessels only and outside of primary intervention during acute STEMI or NSTE-ACS) - Participation in another interventional study Exclusion Criteria: - Previous CABG with patent grafts to the interrogated vessel - Tandem stenoses separated by more than 10 mm that require separate pressure guide wire interrogation or PCI (not to be interrogated or treated as a single stenosis) - Total coronary occlusions - Hemodynamic instability (Killip class III-IV) - Heavily calcified or tortuous vessels - Terminal disease with life expectancy of less than 12 months - STEMI within 48 hours of procedure - Severe valvular heart disease - ACS patients with difficulty in assessing which the culprit lesion is - Significant contraindication to adenosine administration (e.g. Asthma bronchiale) - Pregnancy |
Country | Name | City | State |
---|---|---|---|
Germany | Heart Center Dresden - University Clinic | Dresden | |
Germany | University Clinic Erlangen | Erlangen | |
Germany | Universitätsklinikum Essen | Essen | |
Germany | University Clinic Giessen and Marburg | Gießen | |
Germany | Herzzentrum Leipzig | Leipzig | |
Germany | University Clinic Leipzig | Leipzig | |
Germany | Klinikum der Stadt Ludwigshafen | Ludwigshafen | |
Germany | Lukaskrankenhaus Neuss | Neuss |
Lead Sponsor | Collaborator |
---|---|
Helios Health Institute GmbH | Heart Center Leipzig - University Hospital |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Major Adverse Cardiac Event (MACE) rate | composite of cardiac death, non-fatal myocardial infarction or unplanned revascularization | 1 year | |
Secondary | MACE during long-term follow-up | 2 and 5 years | ||
Secondary | Each component of the primary endpoint assessed by structured telephone interview and verification by hospital reports | 1, 2 and 5 years | ||
Secondary | Repeat revascularization (PCI or CABG) assessed by structured telephone interview and verification by hospital reports in case of event | 1, 2 and 5 years | ||
Secondary | All-cause mortality | 1, 2 and 5 years | ||
Secondary | Cross-over rate from the one strategy to the other | at intervention | ||
Secondary | Number of analyzable lesions in both treatment arms | at intervention |
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