Coronary Artery DiseaseLIPSIASTRATEGYNCT03497637
Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses
A study testing Measurement of FFR and Measurement of vFFR in people with Coronary Artery Disease and Coronary Artery Stenoses, run by Helios Health Institute GmbH at 8 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Stenoses
- What is being tested?
- Measurement of FFR and Measurement of vFFR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,054 participants
- Where
- 8 sitesGermany
- Study dates
- 20 Jun 2020to 5 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 40-90% diameter stenosis).
- Stable angina or acute coronary syndrome (non-culprit vessels only and outside of primary intervention during acute STEMI or NSTE-ACS)
Who cannot join
- 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
Show all 11Show fewer
- STEMI within 24 hours of procedure
- Severe valvular heart disease requiring intervention/surgery
- ACS patients with difficulty in assessing the culprit lesion
- Significant contraindication to adenosine administration (e.g. Asthma bronchiale)
- Pregnancy
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
Heart Center Dresden - University Clinic
Dresden
University Clinic Erlangen
Erlangen
Universitätsklinikum Essen
Essen, 45147
University Clinic Giessen and Marburg
Giessen
Herzzentrum Leipzig
Leipzig
University Clinic Leipzig
Leipzig
Klinikum der Stadt Ludwigshafen
Ludwigshafen
Lukaskrankenhaus Neuss
Neuss
About this study
Official 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.
Read the detailed description
Coronary angiography is insensitive to assess the physiologic significance of a coronary stenosis. Therefore, clinical guidelines support the use of pressure-derived fractional flow reserve (FFR) to assess the hemodynamic significance of coronary stenosis. Nevertheless, the penetration of FFR in clinical routine continues to be limited by its requirement for pharmacological vasodilation, prolonged procedure time and adverse systemic effects from adenosine.
Vessel-FFR (vFFR) is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure drop in the vessel based on computation of two angiographic projections. The vFFR values at each point along the vessel are color-coded and superimposed on the 3D epicardial model and cut-off values of ≤0.80 identical to standard invasive FFR apply.
These developments may translate towards more physiology guided intervention bearing the potential to improve clinical outcomes in patients with stable CAD. The ability to derive FFR values from routinely performed coronary angiograms, without the practical drawbacks that limit invasive techniques, could have an important impact on daily clinical practice.
- Conditions
- Coronary Artery Disease, Coronary Artery Stenoses
- Being tested
- Measurement of FFR, Measurement of vFFR
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of FFRDiagnostic test
Invasive measurement of fractional flow reserve (FFR) using a pressure wire during maximal hyperemia (typically induced by adenosine) to guide revascularization decisions.
Measurement of vFFRDiagnostic test
Computation of vessel fractional flow reserve (vFFR) from coronary angiograms using 3D quantitative coronary angiography (3D-QCA) software to guide revascularization decisions.
| Study group | Role | What they receive |
|---|---|---|
| vFFR-guided PCI | Active comparator | 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. Receives: Diagnostic Test: Measurement of vFFR |
| FFR-guided PCI | Active comparator | 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. Receives: Diagnostic Test: Measurement of FFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac Event (MACE) rate
composite of cardiac death, non-fatal myocardial infarction or unplanned revascularization
Measured: 1 year
Secondary outcomes (6)
MACE during long-term follow-up
Measured: 2 and 5 years
Each component of the primary endpoint assessed by structured telephone interview and verification by hospital reports
Measured: 1, 2 and 5 years
Repeat revascularization (PCI or CABG) assessed by structured telephone interview and verification by hospital reports in case of event
Measured: 1, 2 and 5 years
All-cause mortality
Measured: 1, 2 and 5 years
Cross-over rate from the one strategy to the other
Measured: at intervention
Number of analyzable lesions in both treatment arms
Measured: at intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start20 Jun 2020
- Primary completion12 Feb 2026
- Study completion5 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,054 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helios Health Institute GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Heart Center Leipzig - University Hospital, Leipzig Heart Science gGmbH
- Responsible party
- Sponsor
- Investigators
- Holger Thiele, MD, Principal investigator, Heart Center Leipzig - University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497637
- Sponsor's protocol ID
- HRC045277
- Acronym
- LIPSIASTRATEGY
- Status last verified
- Oct 2026
- First submitted
- 6 Apr 2018
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41923139
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Non-Invasive Vessel Fractional Flow Reserve Calculated From Angiographic Images Versus Fractional Flow Reserve in Patients With Intermediate Coronary Artery Stenoses
- ClinicalTrials.gov ID
- NCT03497637
- Acronym / sponsor ID
- LIPSIASTRATEGY / HRC045277
- Conditions
- Coronary Artery Disease, Coronary Artery Stenoses
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,054 participants (actual)
- Lead sponsor
- Helios Health Institute GmbHUniversity, hospital or other
- Collaborators
- Heart Center Leipzig - University Hospital, Leipzig Heart Science gGmbH
- Study start
- 20 Jun 2020 (actual)
- Primary completion
- 12 Feb 2026 (actual)
- Study completion
- 5 Nov 2029 (estimated)
- First posted
- 13 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Coronary angiography is insensitive to assess the physiologic significance of a coronary stenosis. Therefore, clinical guidelines support the use of pressure-derived fractional flow reserve (FFR) to assess the hemodynamic significance of coronary stenosis. Nevertheless, the penetration of FFR in clinical routine continues to be limited by its requirement for pharmacological vasodilation, prolonged procedure time and adverse systemic effects from adenosine.
Vessel-FFR (vFFR) is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure drop in the vessel based on computation of two angiographic projections. The vFFR values at each point along the vessel are color-coded and superimposed on the 3D epicardial model and cut-off values of ≤0.80 identical to standard invasive FFR apply.
These developments may translate towards more physiology guided intervention bearing the potential to improve clinical outcomes in patients with stable CAD. The ability to derive FFR values from routinely performed coronary angiograms, without the practical drawbacks that limit invasive techniques, could have an important impact on daily clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vFFR-guided PCI | Active comparator | Diagnostic Test: Measurement of vFFRPatients 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. |
| FFR-guided PCI | Active comparator | Diagnostic Test: Measurement of FFRPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 40-90% diameter stenosis).
- Stable angina or acute coronary syndrome (non-culprit vessels only and outside of primary intervention during acute STEMI or NSTE-ACS)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of FFRInvasive measurement of fractional flow reserve (FFR) using a pressure wire during maximal hyperemia (typically induced by adenosine) to guide revascularization decisions. | Diagnostic test | FFR-guided PCI |
| Measurement of vFFRComputation of vessel fractional flow reserve (vFFR) from coronary angiograms using 3D quantitative coronary angiography (3D-QCA) software to guide revascularization decisions. | Diagnostic test | vFFR-guided PCI |
Primary outcome
Major Adverse Cardiac Event (MACE) rate
Time frame: 1 year
composite of cardiac death, non-fatal myocardial infarction or unplanned revascularization
6 secondary outcomes
MACE during long-term follow-up
Time frame: 2 and 5 years
Each component of the primary endpoint assessed by structured telephone interview and verification by hospital reports
Time frame: 1, 2 and 5 years
Repeat revascularization (PCI or CABG) assessed by structured telephone interview and verification by hospital reports in case of event
Time frame: 1, 2 and 5 years
All-cause mortality
Time frame: 1, 2 and 5 years
Cross-over rate from the one strategy to the other
Time frame: at intervention
Number of analyzable lesions in both treatment arms
Time frame: at intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Derived from this study: PubMed 41923139Majunke 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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holger Thiele, MD principal investigator
Heart Center Leipzig - University Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of FFR and Measurement of vFFR in people with Coronary Artery Disease and Coronary Artery Stenoses, run by Helios Health Institute GmbH at 8 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac Event (MACE) rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03497637, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.