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

February 22, 2024 updated by: Giovanni Esposito, Federico II University

Effects of Guiding Catheter on Fractional Flow Reserve and Non-Hyperemic Pressure Ratios 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80131
        • Federico II University of Naples

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patient > 18 years old with coronary artery disease and indication to perform functional assessment

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 minutes
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
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

July 30, 2022

Study Completion (Actual)

July 30, 2022

Study Registration Dates

First Submitted

July 14, 2021

First Submitted That Met QC Criteria

July 14, 2021

First Posted (Actual)

July 23, 2021

Study Record Updates

Last Update Posted (Estimated)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3221

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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