NCT03497637 Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses
| NCT ID | NCT03497637 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Helios Health Institute GmbH |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,054 participants |
| Start Date | 2020-10-23 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,054 participants in total. It began in 2020-10-23 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Holger Thiele, MD
PRINCIPAL INVESTIGATOR
Heart Center Leipzig - University Hospital
Frequently Asked Questions
Who can join the NCT03497637 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03497637 currently recruiting?
Yes, NCT03497637 is actively recruiting participants. Contact the research team at holger.thiele@medizin.uni-leipzig.de for enrollment information.
Where is the NCT03497637 trial being conducted?
This trial is being conducted at Dresden, Germany, Erlangen, Germany, Essen, Germany, Giessen, Germany and 4 additional locations.
Who is sponsoring the NCT03497637 clinical trial?
NCT03497637 is sponsored by Helios Health Institute GmbH. The principal investigator is Holger Thiele, MD at Heart Center Leipzig - University Hospital. The trial plans to enroll 1,054 participants.