LIPSIASTRATEGY
Comparison of Non-Invasive Vessel Fractional Flow Reserve Calculated From Angiographic Images Versus Fractional Flow Reserve in Patients With Intermediate Coronary Artery Stenoses
Sponsor study identifier
interventional
1,054
1 country
8
Study Start
June 20, 2020
Actual (reported)Primary Completion
February 12, 2026
Actual (reported)Study Completion
November 5, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 5, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 6, 2018
Actual (reported)April 13, 2018
Actual (reported)June 20, 2020
Actual (reported)February 12, 2026
Actual (reported)November 5, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Major Adverse Cardiac Event (MACE) rate
composite of cardiac death, non-fatal myocardial infarction or unplanned revascularization
1 year
MACE during long-term follow-up
2 and 5 years
Each component of the primary endpoint assessed by structured telephone interview and verification by hospital reports
1, 2 and 5 years
Repeat revascularization (PCI or CABG) assessed by structured telephone interview and verification by hospital reports in case of event
1, 2 and 5 years
All-cause mortality
1, 2 and 5 years
Cross-over rate from the one strategy to the other
at intervention
Patients undergo percutaneous coronary intervention (PCI) guided by vessel fractional flow reserve (vFFR). vFFR is computed using 3D angiographic reconstruction software to assess the hemodynamic significance of coronary stenoses without the use of an invasive pressure wire or hyperemic agents.
Patients undergo percutaneous coronary intervention (PCI) guided by standard invasive fractional flow reserve (FFR). FFR is measured using an intracoronary pressure wire under maximal hyperemia to assess the hemodynamic significance of coronary stenoses.
Invasive measurement of fractional flow reserve (FFR) using a pressure wire during maximal hyperemia (typically induced by adenosine) to guide revascularization decisions.
Computation of vessel fractional flow reserve (vFFR) from coronary angiograms using 3D quantitative coronary angiography (3D-QCA) software to guide revascularization decisions.
Heart Center Dresden - University Clinic
Dresden, Germany
University Clinic Erlangen
Erlangen, Germany
Universitätsklinikum Essen
Essen, 45147, Germany
University Clinic Giessen and Marburg
Giessen, Germany
Herzzentrum Leipzig
Leipzig, Germany
University Clinic Leipzig
Leipzig, Germany
Klinikum der Stadt Ludwigshafen
Ludwigshafen, Germany
Majunke N, Desch S, Kister T, Buske M, Poss J, Feistritzer HJ, Erbs S, Hosler N, Wolff J, Schneider S, Ouarrak T, Woitek F, Lenk K, Nef H, Dorr O, Sossalla S, Achenbach S, Marwan M, Barlagiannis D, Haude M, Mahabadi AA, Rassaf T, Thiele H. Non-invasive vessel fractional flow reserve versus fractional flow reserve guidance to revascularize intermediate coronary stenosis (LIPSIA-STRATEGY) trial: study protocol for a randomized controlled trial. Trials. 2026 Apr 1;27(1):287. doi: 10.1186/s13063-026-09652-0.
Holger Thiele, MD
Heart Center Leipzig - University Hospital
1,054 participants (actual enrollment reported by the registry).
First Submitted
April 6, 2018
First Posted
April 13, 2018
Study Start
June 20, 2020
Actual (reported)Contact the study team to confirm eligibility.
Lukaskrankenhaus Neuss
Neuss, Germany
Primary Completion
February 12, 2026
Actual (reported)Study Completion
November 5, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 29, 2026
Record last verified: 2026-10
Deidentified individual participant data collected during the LIPSIA-STRATEGY trial, together with a data dictionary, will be made available upon reasonable scientific request, subject to approval by the trial Steering Committee and applicable legal requirements.
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Source: ClinicalTrials.gov.
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