Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses

Coronary Artery Disease Clinical Trial

— LIPSIASTRATEGY  

Official title:

Comparison of Non-Invasive Vessel Fractional Flow Reserve Calculated From Angiographic Images Versus Fractional Flow Reserve in Patients With Intermediate Coronary Artery Stenoses

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03497637
• Other study ID #: HRC045277
• Status: Recruiting
• Phase: N/A
• Start date: October 23, 2020
• Est. completion date: November 1, 2026

Study information

• Verified date: September 2023
• Source: Helios Health Institute GmbH
• Contact: Holger Thiele, MD
• Phone: +49 341 865 1428
• Email: holger.thiele[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. To date no randomized outcome-based clinical trial has compared an image-based FFR methodology with standard invasive FFR in terms of subsequent clinical outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1926
• Est. completion date: November 1, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Coronary Artery Disease
• Coronary Artery Stenoses
• Coronary Stenosis

Intervention

Diagnostic Test:
• measurement of FFR
use of pressure-derived FFR to assess the hemodynamic significance of coronary stenoses
• measurement of Pd/Pa
use of resting distal coronary pressure to aortic pressure ratio (Pd/Pa) to assess the hemodynamic significance of coronary stenoses

Locations

Country	Name	City	State
Germany	Heart Center Dresden - University Clinic	Dresden
Germany	University Clinic Erlangen	Erlangen
Germany	Universitätsklinikum Essen	Essen
Germany	University Clinic Giessen and Marburg	Gießen
Germany	Herzzentrum Leipzig	Leipzig
Germany	University Clinic Leipzig	Leipzig
Germany	Klinikum der Stadt Ludwigshafen	Ludwigshafen
Germany	Lukaskrankenhaus Neuss	Neuss

Sponsors (2)

Lead Sponsor	Collaborator
Helios Health Institute GmbH	Heart Center Leipzig - University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiac Event (MACE) rate	composite of cardiac death, non-fatal myocardial infarction or unplanned revascularization	1 year
Secondary	MACE during long-term follow-up		2 and 5 years
Secondary	Each component of the primary endpoint assessed by structured telephone interview and verification by hospital reports		1, 2 and 5 years
Secondary	Repeat revascularization (PCI or CABG) assessed by structured telephone interview and verification by hospital reports in case of event		1, 2 and 5 years
Secondary	All-cause mortality		1, 2 and 5 years
Secondary	Cross-over rate from the one strategy to the other		at intervention
Secondary	Number of analyzable lesions in both treatment arms		at intervention