NCT03497637Active, not recruiting
Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses
Comparison of Non-Invasive Vessel Fractional Flow Reserve Calculated From Angiographic Images Versus Fractional Flow Reserve in Patients With Intermediate Coronary Artery Stenoses
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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 (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 1054 (actual)
- First submitted
- 6 Apr 2018
- Start date
- 20 Jun 2020
- Primary completion date
- 12 Feb 2026
- Lead sponsor
- Helios Health Institute GmbH
- Diseases
- Coronary artery disease
- NCT number
- NCT03497637
What you commit to
- Study type: Interventional
- Participants enrolled: 1054
- From 20 Jun 2020 to the primary completion date, 12 Feb 2026
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous CABG with patent grafts to the interrogated vessel
Other illness
- Terminal disease with life expectancy of less than 12 months
- Severe valvular heart disease requiring intervention/surgery
Other
- 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
- STEMI within 24 hours of procedure
- ACS patients with difficulty in assessing the culprit lesion
- Significant contraindication to adenosine administration (e.g. Asthma bronchiale)
- Pregnancy
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Heart Center Dresden - University Clinic Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| University Clinic Erlangen Coordinator of this site? Confirm its status | Erlangen | Germany | Unknown status |
| Universitätsklinikum Essen Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| University Clinic Giessen and Marburg Coordinator of this site? Confirm its status | Giessen | Germany | Unknown status |
| Herzzentrum Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| University Clinic Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| Klinikum der Stadt Ludwigshafen Coordinator of this site? Confirm its status | Ludwigshafen | Germany | Unknown status |
| Lukaskrankenhaus Neuss Coordinator of this site? Confirm its status | Neuss | Germany | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.