Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03497637
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : October 27, 2020
Sponsor:
Collaborator:
Heart Center Leipzig - University Hospital
Information provided by (Responsible Party):
Leipzig Heart Institute GmbH

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Coronary Artery Stenoses Diagnostic Test: measurement of FFR Diagnostic Test: measurement of Pd/Pa Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1926 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 23, 2020
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2026

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




Primary Outcome Measures :
  1. Major Adverse Cardiac Event (MACE) rate [ Time Frame: 1 year ]
    composite of cardiac death, non-fatal myocardial infarction or unplanned revascularization


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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03497637


Contacts
Layout table for location contacts
Contact: Holger Thiele, MD +49 341 865 1428 holger.thiele@medizin.uni-leipzig.de

Locations
Layout table for location information
Germany
Herzzentrum Leipzig Recruiting
Leipzig, Germany
Contact: Holger Thiele, MD         
Sponsors and Collaborators
Leipzig Heart Institute GmbH
Heart Center Leipzig - University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Holger Thiele, MD Heart Center Leipzig - University Hospital
Layout table for additonal information
Responsible Party: Leipzig Heart Institute GmbH
ClinicalTrials.gov Identifier: NCT03497637    
Other Study ID Numbers: HRC045277
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Coronary Stenosis
Constriction, Pathologic
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathological Conditions, Anatomical