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Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses

NCT03497637 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1054

Last updated 2024-11-25

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

measurement of FFR

use of pressure-derived FFR 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

Sponsors & Collaborators

  • Heart Center Leipzig - University Hospital

    collaborator OTHER

  • Helios Health Institute GmbH

    lead OTHER

Principal Investigators

  • Holger Thiele, MD · Heart Center Leipzig - University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-23
Primary Completion
2026-05-01
Completion
2026-11-01

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03497637 on ClinicalTrials.gov