NL-OMON54348
Recruiting
Not Applicable
Fractional Flow Reserve or 3D-Quantitative-Coronary-Angiography Based Vessel-FFR guided revascularization - FAST III
European Cardiovascular Research Institute0 sites800 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intermediate coronary artery stenosis
- Sponsor
- European Cardiovascular Research Institute
- Enrollment
- 800
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •2\. Presenting with silent ischemia, stable angina, non\-ST\-elevation acute
- •coronary syndrome (NSTE\-ACS), or stabilized STEMI (\>72h post culprit treatment)
- •3\. Coronary artery disease with at least one native artery in which the
- •stenosis severity is questionable (typically 30\-80% stenosis)
- •4\. vFFR guided revascularization considered feasible (see vFFR training manual)
Exclusion Criteria
- •1\. Acute treatment of ST\-elevation myocardial infarction (STEMI)
- •2\. Cardiogenic shock or severe hemodynamic instability at the time of
- •intervention (as defined by the interventionalist) or use of left ventricular
- •assist device
- •3\. A study lesion cannot be in a vessel with a distal Thrombolysis In
- •Myocardial Infarction (TIMI) flow \<3\.
- •4\. A study lesion cannot have evidence of thrombus.
- •5\. Known untreated severe valvular heart disease
- •6\. A study lesion cannot be located in or supplied by an arterial or venous
- •bypass graft
Outcomes
Primary Outcomes
Not specified
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