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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03082989 |
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Date of registration:
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13/03/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Evolving Routine Standards in Intracoronary Physiology
ERIS |
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Scientific title:
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Prospective Study Evaluating the Routine Standard Use of Fractional Flow Reserve and Disagreement With Guideline Recommendations: a Nationwide Study |
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Date of first enrolment:
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March 13, 2017 |
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Target sample size:
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1858 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03082989 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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Italy
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Contacts
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Name:
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Massimo Fineschi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AOU Siena |
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Name:
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Giuseppe Musumeci, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AOU Cuneo |
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Name:
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Gianluca Campo, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AOU Ferrara |
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Name:
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Giulio Stefanino, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Humanitas, Rozzano (MI) |
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Name:
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Matteo Tebaldi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AOU Ferrara |
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Name:
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Marco Luciano Rossi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Humanitas, Rozzano (MI) |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
FRACTIONAL FLOW RESERVE PERFORMED GROUP
- age >18 years
- written consent
- assessment with FFR of at least one coronary lesion
FRACTIONAL FLOW RESERVE NOT PERFORMED GROUP
- age >18 years
- written consent
- absence of assessment with FFR of at least one coronary lesion
+ at least one of the following criteria
1. stable coronary artery disease, absence of non-invasive stress test, evidence of
coronary lesions between 50%-90% (visual estimation or quantitative coronary
analysis)
2. stable coronary artery disease, presence of non-invasive stress test, evidence of
coronary lesions between 50%-70% (visual estimation or quantitative coronary
analysis)
3. acute coronary syndrome, culprit lesion not identifiable or coronary lesions
different from the culprit between 50%-70% (visual estimation or quantitative
coronary analysis)
Exclusion Criteria:
- written consent denied
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Myocardial Ischemia
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Intervention(s)
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Device: fractional flow reserve performed
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Other: fractional flow reserve not performed
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Primary Outcome(s)
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agreement with current guidelines
[Time Frame: intra-procedure]
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Secondary Outcome(s)
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reasons leading to FFR disuse
[Time Frame: intra-procedure]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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