An interventional study of Measurement of FFR and Measurement of vFFR in Coronary Artery Disease and Coronary Artery Stenoses, sponsored by Helios Health Institute GmbH. Active, not recruiting at 8 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Helios Health Institute GmbH · Not applicable, Interventional, and Treatment
Among 365 studies in Coronary Artery Disease with a site in Germany — 46 open to participants now, 71 under way, 3 of them phase 3. Coronary Artery Disease · Germany.
Among the 365 studies in Coronary Artery Disease with a site in Germany, this one is the 58th largest by enrollment of the 248 interventional ones that give a count, is one of 19 that started in 2020, is one of 128 with no phase, reaches primary completion later than 22 of the 70 other live ones, and was the 255th registered.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's enrollment of 1,054 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →46 of the 365 studies in Coronary Artery Disease with a site in Germany are open now.
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 588 Coronary Artery Disease studies recruiting now, 402 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 47 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →365 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 15 · Phase 2 32 · Phase 3 39 · Phase 4 47
First in 1999; this study’s year is marked. 19 started in 2020.
Median enrollment 265 across the 248 interventional studies, 550 across the 117 observational. Of the 237 that completed or were terminated, 56 (24%) have results posted.
171 of 365 have an industry lead sponsor. The 10 most frequent:
Helios Health Institute GmbH is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
Helios Health Institute GmbH has 2 studies filed under Coronary Artery Disease — fewer than ten, so there is no comparison to draw.
13 of the studies in Coronary Artery Disease with a site in Germany that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04196712University Hospital, EssenEssen Coronary Artery Disease Registry | 2026-12-30 |
| NCT03820492Insel Gruppe AG, University Hospital BernComparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT | 2026-12-31 |
| NCT05540223Biotronik AGSafety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System | 2027-02 |
| NCT06678490OrbusNeichSupport C Post-Market Registry | 2027-02 |
| NCT06535854Medtronic VascularPrevail Global Study | 2027-02 |
Among the 365 studies in Coronary Artery Disease with a site in Germany, from their registry updates:
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.
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.
The criteria were revised on the registry on Oct 29, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: Measurement of vFFR
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.
Diagnostic Test: Measurement of FFR
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.
Major Adverse Cardiac Event (MACE) rate
composite of cardiac death, non-fatal myocardial infarction or unplanned revascularization
Time frame: 1 year
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
Plan to share: 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.
Time frame: Data will be available upon publication of the primary trial results. The duration of availability will be determined in accordance with applicable legal and institutional requirements.
Access criteria: Researchers may submit a scientifically justified request to the corresponding authors, including a full study protocol and statistical analysis plan for the proposed research. Requests will be reviewed by the trial Steering Committee, and access will be granted subject to scientific approval and applicable legal requirements.
Ran from Jun 2020 to primary completion in Feb 2026, 67 months.
Of 753 non-industry interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's 67 months is above that.
Counting every sponsor, half of 930 studies reached it within 30 months; a quarter within 15 and three quarters within 50.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 29, 2026: start Oct 2020 → Jun 2020, primary completion May 2026 → Feb 2026 and completion Nov 2026 → Nov 2029.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Helios Health Institute GmbH