Effects of Guiding Catheter on FFR and NHPR for the Assessment of Coronary Artery Stenoses (Disengage@Rest)

The DISENGAGE@rest study is a prospective registry carried out at Federico II University of Naples with the aim to evaluate the influence of the guiding catheter engagement within the coronary ostium on both FFR and non-hyperaemic pressure ratios values (such as Pd/Pa and the Resting Full-cycle Ratio -RFR), as well as the corresponding clinical impact on decision-making strategies. Consecutive patients with at least one intermediate stenosis (40%-90% by visual estimation) in any of the 3 main coronary arteries will be included.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Federico II University of Naples

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age > 18 years;
Patients provides informed consent;
Documented coronary artery disease:
chronic coronary syndromes
acute coronary syndromes presenting with at least one stenosis with indication for invasive functional assessment.

Exclusion criteria

Patients unable to provide informed consent;
Pregnant women;
Any contraindication to perform angiographic study or functional evaluation with pressure wire;
Patients with aorto-ostial stenosis
Target vessel diameter < 2mm

Treatment and study plan

Fractional flow reserve

Diagnostic Test

Comparison between FFR and NHPR before and after guiding catheter disengagement

Other names: RFR, Pd/Pa

Primary outcomes

Differences between FFR before and after guiding catheter disengagement

Time frame: 10 minutes

Evaluate the influence of the guiding catheter engagement within the coronary ostium on FFR values.
1. Differences between NHPR before and after guiding catheter disengagement

Time frame: 10 minutes

Evaluate the influence of the guiding catheter engagement within the coronary ostium on NHPR values

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

Effects of Guiding Catheter on Fractional Flow Reserve and Non-Hyperemic Pressure Ratios for the Assessment of Coronary Artery Stenoses - Disengage @Rest

Acronym: Disengage@Rest

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jul 23, 2021
Registry last updated: Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed