Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses

NCT03497637 | Recruiting

• 1 other identifier: HRC045277
• Study Type: interventional
• Target: 1,054
• Locations: 1 country
• Sites: 8

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.

Conditions

Coronary Artery Disease; Coronary Artery Stenoses

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiac Event (MACE) rate

  composite of cardiac death, non-fatal myocardial infarction or unplanned revascularization

  1 year

Secondary Outcomes (6)

• 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

Study Arms (2)

Pd/Pa guided Therapy

ACTIVE COMPARATOR

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

FFR guided therapy

ACTIVE COMPARATOR

use of pressure-derived FFR to assess the hemodynamic significance of coronary stenoses

Diagnostic Test: measurement of FFR

Interventions

measurement of FFR DIAGNOSTIC_TEST

use of pressure-derived FFR to assess the hemodynamic significance of coronary stenoses

FFR guided therapy

measurement of Pd/Pa DIAGNOSTIC_TEST

use of resting distal coronary pressure to aortic pressure ratio (Pd/Pa) to assess the hemodynamic significance of coronary stenoses

Pd/Pa guided Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helios Health Institute GmbH: lead
• Heart Center Leipzig - University Hospital: collaborator

Study Sites (8)

Heart Center Dresden - University Clinic

Dresden, Germany

RECRUITING

University Clinic Erlangen

Erlangen, Germany

RECRUITING

Universitätsklinikum Essen

Essen, 45147, 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

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Holger Thiele, MD

  Heart Center Leipzig - University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Holger Thiele, MD

CONTACT

+49 341 865 1428; holger.thiele@medizin.uni-leipzig.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: April 13, 2018
• Study Start: October 23, 2020
• Primary Completion: May 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (8)