Comparing two methods for assessing coronary artery blockages
Comparison of Non-Invasive Vessel Fractional Flow Reserve Calculated From Angiographic Images Versus Fractional Flow Reserve in Patients With Intermediate Coronary Artery Stenoses
NA · Helios Health Institute GmbH · NCT03497637
This study is testing a new way to check for blockages in heart arteries to see if it works as well as the standard method for people with stable coronary artery disease.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1054 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Helios Health Institute GmbH (other) |
| Locations | 8 sites (Dresden and 7 other locations) |
| Trial ID | NCT03497637 on ClinicalTrials.gov |
What this trial studies
This clinical trial is designed to evaluate the effectiveness of Vessel-FFR (vFFR) compared to the standard fractional flow reserve (FFR) in assessing intermediate coronary stenosis. It is a prospective, randomized, controlled, multicenter, open-label study that aims to determine if vFFR is non-inferior to FFR in terms of major adverse cardiac events (MACE) over a 12-month period. The study utilizes a novel method that calculates pressure drop based on angiographic images, potentially allowing for more efficient and less invasive assessments of coronary artery disease. By comparing these two methodologies, the trial seeks to improve clinical outcomes for patients with stable coronary artery disease.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with stable angina or acute coronary syndrome who are eligible for coronary angiography and have intermediate coronary stenosis.
Not a fit: Patients with total coronary occlusions or those experiencing hemodynamic instability may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more accessible and less invasive method for evaluating coronary artery blockages, improving patient outcomes.
How similar studies have performed: This approach is novel, as no previous randomized outcome-based clinical trial has compared image-based FFR methodology with standard invasive FFR in terms of clinical outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dresden and 7 other locations
- Heart Center Dresden - University Clinic — Dresden, Germany (RECRUITING)
- University Clinic Erlangen — Erlangen, Germany (RECRUITING)
- Universitätsklinikum Essen — Essen, Germany (RECRUITING)
- University Clinic Giessen and Marburg — Giessen, Germany (RECRUITING)
- Herzzentrum Leipzig — Leipzig, Germany (RECRUITING)
- University Clinic Leipzig — Leipzig, Germany (RECRUITING)
- Klinikum der Stadt Ludwigshafen — Ludwigshafen, Germany (RECRUITING)
- Lukaskrankenhaus Neuss — Neuss, Germany (RECRUITING)
Study contacts
- Principal investigator: Holger Thiele, MD — Heart Center Leipzig - University Hospital
- Study coordinator: Holger Thiele, MD
- Email: holger.thiele@medizin.uni-leipzig.de
- Phone: +49 341 865 1428
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Artery Disease, Coronary Artery Stenoses