Clinical trial NCT04975425: Effects of Guiding Catheter on FFR and NHPR for the Assessment of Coronary Artery Stenoses (Disengage@Rest)
Official title: Effects of Guiding Catheter on Fractional Flow Reserve and Non-Hyperemic Pressure Ratios for the Assessment of Coronary Artery Stenoses - Disengage @Rest
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Fractional Flow Reserve
Resting Full-Cycle Ratio
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient \> 18 years old with coronary artery disease and indication to perform functional assessment

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.


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

Primary outcomes:
measure: Differences between FFR before and after guiding catheter disengagement
timeFrame: 10 minutes
measure: 1. Differences between NHPR before and after guiding catheter disengagement
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Federico II University of Naples
Study officials:
References:
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