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FFR guided PCI optimization directed by high-definition IVUS versus standard of care: the randomized FFR-REACT trial

Completed
Conditions
coronary artery narrowing
coronary artery stenosis
10003216
Registration Number
NL-OMON50576
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
640
Inclusion Criteria

1. Age >=18
2. Stable- or unstable angina or Non-ST segment elevation myocardial infarction
3. Target lesion stenosis >= 50% by visual estimation or QCA

Exclusion Criteria

1. Patients with ST-elevation myocardial infarction (STEMI) or evidence of
myocardial infarction within 72 hours before the index procedure
2. Target vessel distal reference diameter <2.25mm
3. Cardiogenic shock or severe hemodynamic instability
4. Inability to perform post procedure FFR
5. The patient has other medical illnesses (i.e., cancer) that may cause the
patient to be non-compliant with the protocol, confound the data interpretation
or is associated with limited life expectancy (i.e., less than one year).

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Target vessel failure (TVF), a composite of cardiac death, target-vessel<br /><br>myocardial infarction and clinically driven TVR at 1 year.</p><br>
Secondary Outcome Measures
NameTimeMethod
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