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

NCT ID: NCT04975425

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2022-07-30

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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Fractional Flow Reserve

Comparison between FFR and NHPR before and after guiding catheter disengagement

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

RFR; Pd/Pa

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Giovanni Esposito

Full Professor of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federico II University of Naples

Naples, , Italy

Countries

Italy

References

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Other Identifiers

3221

Identifier Type: -

Identifier Source: org_study_id