RFR and FFR for the the Prediction of Post-PCI Results

NCT04417634 | Unknown Phase 4

• 1 other identifier: 2020-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to record hemodynamic pullback information using continuous resting full-cycle flow ratio (RFR) and fractional flow reserve (FFR) in patients with diffuse coronary artery disease. The capacity of the two indexes to predict the hemodynamic outcome after stenting will be compared. Goals of the study are:

• To study the accuracy of RFR/FFR gradients in predicting the change in whole-vessel RFR/FFR after PCI.
• To identify a threshold in the RFR/FFR gradient that is predictive of pathological RFR/FFR also after the PCI of the first lesion.

Conditions

Coronary Artery Disease

Keywords

stent; coronary stenosis; Angina

Outcome Measures

Primary Outcomes (1)

• Absolute difference between RFR observed and expected as compared to FFR observed versus expected.

  Comparison of \|RFRexp-RFRobs\| vs. \|FFRexp-FFRobs\| (i.e., absolute differences between expected and observed final hemodynamic result) RFRexp and FFRexp are defined as (RFRbas plus RFRGrad) and (FFRbas plus FFRGrad)

  1 day

Study Arms (2)

RFR: resting full-cycle ratio

EXPERIMENTAL

RFR will be used to drive PCI

Diagnostic Test: RFR

FFR: fractional flow reserve

ACTIVE COMPARATOR

FFR will be used to drive PCI

Diagnostic Test: FFR

Interventions

RFR DIAGNOSTIC_TEST

Measurement of resting flow ratio

RFR: resting full-cycle ratio

FFR DIAGNOSTIC_TEST

Measurement of fractional flow reserve

FFR: fractional flow reserve

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented heart team (when applicable, as per guidelines) decision for revascularization via PCI
• Patient ≥18 years old

You may not qualify if:

• Cardiogenic shock
• Any contraindication to PCI according to guidelines
• Presence of a coronary artery bypass grafting (CABG) in the territory under study
• Culprit vessels in patients with ST-segment elevation myocardial infarction (STEMI)
• TIMI (Thrombolysis in Myocardial Infarction) flow grade \< 3
• Lesion severity \> 90% by visual assessment
• Presence of thrombus
• Participation in another randomized interventional study
• Patient unable to give informed consent
• Women of child-bearing potential or lactating

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Study Sites (1)

Center of Cardiology, Cardiology I, university hospital Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis; Angina Pectoris

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tommaso Gori

CONTACT

+491721052846; tomgori@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: The study is a single-center, randomized superiority trial to compare two strategies for the assessment of the hemodynamic relevance of coronary lesions.

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 5, 2020
• Study Start: May 10, 2020
• Primary Completion: June 10, 2025
• Study Completion: June 10, 2025
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)