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

Sponsor
Federico II University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04975425
Collaborator
(none)
200
Enrollment
1
Location
12.9
Anticipated Duration (Months)
15.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Fractional Flow Reserve

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Effects of Guiding Catheter on Fractional Flow Reserve and Non-Hyperemic Pressure Ratios for the Assessment of Coronary Artery Stenoses - Disengage @Rest
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Jul 30, 2022
Anticipated Study Completion Date :
Jul 30, 2022

Outcome Measures

Primary Outcome Measures

  1. Differences between FFR before and after guiding catheter disengagement [10 minutes]

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

  2. 1. Differences between NHPR before and after guiding catheter disengagement [10 minutes]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Federico II University of Naples Naples Italy 80131

Sponsors and Collaborators

  • Federico II University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Giovanni Esposito, Full Professor of Cardiology, Federico II University
ClinicalTrials.gov Identifier:
NCT04975425
Other Study ID Numbers:
  • 3221
First Posted:
Jul 23, 2021
Last Update Posted:
Jul 23, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Giovanni Esposito, Full Professor of Cardiology, Federico II University
Fractional Flow Reserve
Resting Full-Cycle Ratio
Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Stenosis

Study Results

No Results Posted as of Jul 23, 2021