Actively Recruiting
Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses
Led by Helios Health Institute GmbH · Updated on 2024-11-25
1054
Participants Needed
8
Research Sites
314 weeks
Total Duration
On this page
Sponsors
H
Helios Health Institute GmbH
Lead Sponsor
H
Heart Center Leipzig - University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age >18 years
- Willing and able to understand, read, and sign informed consent before the procedure
- Eligible for coronary angiography and/or PCI
- Coronary artery disease in one or more native major epicardial vessels or branches with visually assessed new coronary stenosis of uncertain severity (typically 40-80% diameter narrowing)
- Stable angina or acute coronary syndrome (only in non-culprit vessels and outside primary intervention during acute STEMI or NSTE-ACS)
- Participation in another interventional study
You will not qualify if you...
- Previous coronary artery bypass graft surgery with patent grafts to the studied vessel
- Tandem stenoses more than 10 mm apart requiring separate pressure wire assessment or PCI
- Complete coronary artery occlusions
- Hemodynamic instability classified as Killip class III-IV
- Very calcified or twisted vessels
- Terminal illness with life expectancy under 12 months
- STEMI within 48 hours before procedure
- Severe valvular heart disease
- Acute coronary syndrome patients with unclear culprit lesion
- Significant contraindications to adenosine (e.g., asthma)
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Heart Center Dresden - University Clinic
Dresden, Germany
Actively Recruiting
2
University Clinic Erlangen
Erlangen, Germany
Actively Recruiting
3
Universitätsklinikum Essen
Essen, Germany, 45147
Actively Recruiting
4
University Clinic Giessen and Marburg
Giessen, Germany
Actively Recruiting
5
Herzzentrum Leipzig
Leipzig, Germany
Actively Recruiting
6
University Clinic Leipzig
Leipzig, Germany
Actively Recruiting
7
Klinikum der Stadt Ludwigshafen
Ludwigshafen, Germany
Actively Recruiting
8
Lukaskrankenhaus Neuss
Neuss, Germany
Actively Recruiting
Research Team
H
Holger Thiele, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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