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NCT03588455 Clinical Trial

Pronostic Impact of Flow Fraction Reserve on Intermediate Stenoses

Coronary Stenosis Clinical Trial

Official title:
Pronostic Impact of Flow Fraction Reserve on Intermediate Stenoses

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03588455
Other study ID # FFR
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date June 30, 2018

Study information
Verified date August 2018
Source Groupe Hospitalier Paris Saint Joseph
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The intermediate coronary stenoses defined by a degree of stenosis from 40 to 70 % are frequent. The Flow Fraction Reserve (FFR), realized during coronarography, is an hemodynamic evaluation by the functional impact measuring the loss of load in upstream / approval of the stenosis inthe basal state and in situation of hyperemia led by adenosine. Further to the study FAME, the threshold of definition of the significant character of one Stenosis was fixed for a value of FFR = 0,80. However, the impact forecasts intermediate values badly known rest.

We hypothetized that coronary stenosis associated with borderline values of FFR 0.81-0.85 were associated with a higher rate of clinical events than those with a FFR >0.85

Recruitment information / eligibility
Status Completed
Enrollment 91
Est. completion date June 30, 2018
Est. primary completion date April 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patient with FFR> 0,80 between september 2012 till december 2016

Exclusion Criteria:

- refusal of participation

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Groupe Hospitalier Paris Saint Joseph Paris Ile-de-France

Sponsors (1)
Lead Sponsor Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Composite outcome cardiovascular mortality or acute coronary syndrom or revascularization or cardiovascular rehospitalisation 3 years
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