Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses (LIPSIASTRATEGY)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Coronary Artery Stenoses
• Intervention / Treatment: Diagnostic test: measurement of Pd/Pa; Diagnostic test: measurement of FFR

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 1054
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Holger Thiele, MD; Phone Number: +49 341 865 1428; Email: holger.thiele@medizin.uni-leipzig.de

Study Locations

• Germany
  • Dresden, Germany
    • Recruiting
    • Heart Center Dresden - University Clinic
    • Contact: Felix Woitek, Dr.
  • Erlangen, Germany
    • Recruiting
    • University Clinic Erlangen
    • Contact: Luise Gaede, Dr.
  • Essen, Germany, 45147
    • Recruiting
    • Universitatsklinikum Essen
    • Contact: Tienush Rassaf, Prof. Dr.
  • Gießen, Germany
    • Recruiting
    • University Clinic Giessen and Marburg
    • Contact: Holger Nef, Prof.
  • Leipzig, Germany
    • Recruiting
    • Herzzentrum Leipzig
    • Contact: Holger Thiele, MD
  • Leipzig, Germany
    • Recruiting
    • University Clinic Leipzig
    • Contact: Ulrich Laufs, Prof.
  • Ludwigshafen, Germany
    • Recruiting
    • Klinikum der Stadt Ludwigshafen
    • Contact: Uwe Zeymer, Prof.
  • Neuss, Germany
    • Recruiting
    • Lukaskrankenhaus Neuss
    • Contact: Michael Haude, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pd/Pa guided Therapy; use of resting distal coronary pressure to aortic pressure ratio (Pd/Pa) to assess the hemodynamic significance of coronary stenoses	Diagnostic test: measurement of Pd/Pa; use of resting distal coronary pressure to aortic pressure ratio (Pd/Pa) to assess the hemodynamic significance of coronary stenoses
Active Comparator: FFR guided therapy; use of pressure-derived FFR to assess the hemodynamic significance of coronary stenoses	Diagnostic test: measurement of FFR; use of pressure-derived FFR to assess the hemodynamic significance of coronary stenoses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiac Event (MACE) rate	composite of cardiac death, non-fatal myocardial infarction or unplanned revascularization	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
MACE during long-term follow-up	2 and 5 years
Each component of the primary endpoint assessed by structured telephone interview and verification by hospital reports	1, 2 and 5 years
Repeat revascularization (PCI or CABG) assessed by structured telephone interview and verification by hospital reports in case of event	1, 2 and 5 years
All-cause mortality	1, 2 and 5 years
Cross-over rate from the one strategy to the other	at intervention
Number of analyzable lesions in both treatment arms	at intervention

Collaborators and Investigators

• Sponsor: Helios Health Institute GmbH
• Collaborators: Heart Center Leipzig - University Hospital
• Investigators: Principal Investigator: Holger Thiele, MD, Heart Center Leipzig - University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2020
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: April 6, 2018
• First Submitted That Met QC Criteria: April 12, 2018
• First Posted (Actual): April 13, 2018

Study Record Updates

• Last Update Posted (Actual): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Constriction, Pathologic; Coronary Artery Disease; Coronary Stenosis
• Other Study ID Numbers: HRC045277

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No